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Control of Major Bleeding After Trauma Study (COMBAT)

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ClinicalTrials.gov Identifier: NCT01838863
Recruitment Status : Terminated (Futility.)
First Posted : April 24, 2013
Results First Posted : July 18, 2018
Last Update Posted : July 18, 2018
Sponsor:
Collaborators:
U.S. Army Medical Research and Materiel Command
University of Colorado, Denver
Information provided by (Responsible Party):
Ernest E. Moore, MD, Denver Health and Hospital Authority

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Trauma
Hemorrhagic Shock
Interventions Biological: Type AB plasma
Drug: Crystalloid fluid (standard of care for resuscitation)
Enrollment 144
Recruitment Details  
Pre-assignment Details The enrollment and randomization occurred almost simultaneously. Once the paramedics determined the patient to be eligible, the cooler was opened and the randomization was done based on the cooler content: cooler with plasma randomized the patient to the experimental and cooler with frozen water randomized the patient to the control group.
Arm/Group Title Plasma Standard
Hide Arm/Group Description

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Period Title: Overall Study
Started 75 69
Completed 65 60
Not Completed 10 9
Arm/Group Title Plasma Standard Total
Hide Arm/Group Description

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Total of all reporting groups
Overall Number of Baseline Participants 65 60 125
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 65 participants 60 participants 125 participants
33
(25 to 51)
32.5
(25.8 to 42)
33
(25 to 47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 60 participants 125 participants
Female
13
  20.0%
9
  15.0%
22
  17.6%
Male
52
  80.0%
51
  85.0%
103
  82.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 60 participants 125 participants
Hispanic or Latino
34
  52.3%
39
  65.0%
73
  58.4%
Not Hispanic or Latino
31
  47.7%
21
  35.0%
52
  41.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 65 participants 60 participants 125 participants
65 60 125
Body Mass Index (BMI)  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 65 participants 60 participants 125 participants
27.1
(23.9 to 30.5)
26.1
(23.2 to 29.4)
26.7
(23.4 to 30.5)
Comorbidities   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 60 participants 125 participants
10
  15.4%
8
  13.3%
18
  14.4%
[1]
Measure Description: Presence of one or more additional diseases or disorders co-occurring in trauma patient.
Blunt injury mechanism   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 60 participants 125 participants
30
  46.2%
32
  53.3%
62
  49.6%
[1]
Measure Description: Blunt force trauma is an injury that occurs when an object hits or strikes a part of the body.
New Injury Severity Scale (NISS)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 65 participants 60 participants 125 participants
27
(10 to 41)
27
(11.8 to 35)
27
(10 to 38)
[1]
Measure Description: The New Injury Severity Score (NISS) is an anatomical scoring system that provides an overall score for patients with multiple injuries. This is calculated as the sum of the squares of the top three Abbreviated Injury Scores (AIS) regardless of body region. AIS is an anatomical-based coding system on a scale of one to six, one being a minor injury and six being maximal. The NISS score takes values from 0 to 75. This score is virtually the only anatomical scoring system in use and correlates linearly with mortality, morbidity, hospital stay and other measures of severity.
Maximal Abbreviated Injury Score (AIS) for head and neck   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 65 participants 60 participants 125 participants
0
(0 to 2)
0
(0 to 2.3)
0
(0 to 2)
[1]
Measure Description: Abbreviated Injury Score is an anatomical-based coding system on a scale of one to six, one being a minor injury and six being maximal.
Traumatic Brain Injury (TBI) defined as AIS head >=3  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 60 participants 125 participants
15
  23.1%
13
  21.7%
28
  22.4%
Maximal Abbreviated Injury Score (AIS) chest   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 65 participants 60 participants 125 participants
1
(0 to 3)
3
(0 to 3)
2
(0 to 3)
[1]
Measure Description: Abbreviated Injury Score is an anatomical-based coding system on a scale of one to six, one being a minor injury and six being maximal.
Maximal Abbreviated Injury Score (AIS) abdomen and pelvis   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 65 participants 60 participants 125 participants
0
(0 to 3)
0
(0 to 3)
0
(0 to 3)
[1]
Measure Description: Abbreviated Injury Score is an anatomical-based coding system on a scale of one to six, one being a minor injury and six being maximal.
Maximal Abbreviated Injury Score (AIS) extremities   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 65 participants 60 participants 125 participants
1
(0 to 3)
0
(0 to 2)
0
(0 to 2)
[1]
Measure Description: Abbreviated Injury Score is an anatomical-based coding system on a scale of one to six, one being a minor injury and six being maximal.
Heart rate (HR) in the field  
Median (Inter-Quartile Range)
Unit of measure:  Beats per minute (BPM)
Number Analyzed 65 participants 60 participants 125 participants
110
(98 to 120)
112
(100 to 120)
110
(100 to 120)
Systolic blood pressure (SBP) in the field  
Median (Inter-Quartile Range)
Unit of measure:  mmHg
Number Analyzed 65 participants 60 participants 125 participants
64
(50 to 80)
70
(58 to 80)
68
(50 to 80)
Severe shock defined as systolic blood pressure (SBP) in the field <=70mmHg  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 60 participants 125 participants
44
  67.7%
33
  55.0%
77
  61.6%
Body temperature in the field   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Degrees Celsius
Number Analyzed 38 participants 29 participants 67 participants
36
(34.8 to 36.6)
36
(35.1 to 37)
36
(34.9 to 36.9)
[1]
Measure Analysis Population Description: The body temperature was measured in the field with a temporal scanner infrared thermometer. Due to the specifics of the study (acute trauma setting), it was not always possible to obtain a body temperature reading in the field (accident scene).
Glasgow Coma Scale (GCS) in the field   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 65 participants 60 participants 125 participants
14
(7 to 15)
14
(8 to 15)
14
(8 to 15)
[1]
Measure Description: Glasgow Coma Scale (GCS) is a neurological scale which aims to give a reliable and objective way of recording the conscious state of a person for initial as well as subsequent assessment. The GCS is the summation of scores for eye, verbal, and motor responses. The minimum score is a 3 which indicates deep coma or a brain-dead state. The maximum is 15 which indicates a fully awake patient.
Haemoglobin (Hb) in the field   [1] 
Median (Inter-Quartile Range)
Unit of measure:  g/dL
Number Analyzed 32 participants 27 participants 59 participants
15.1
(13.6 to 15.7)
14.2
(13.2 to 15.9)
14.6
(13.2 to 15.7)
[1]
Measure Analysis Population Description: Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).
Platelet count in the field   [1] 
Median (Inter-Quartile Range)
Unit of measure:  1000 cells/microL
Number Analyzed 26 participants 20 participants 46 participants
300.5
(251.8 to 353.2)
273.5
(219 to 331)
287.5
(245.5 to 345.8)
[1]
Measure Analysis Population Description: Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).
Fibrinogen in the field   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 35 participants 29 participants 64 participants
253
(226 to 308)
278
(250 to 331)
268
(228.5 to 322.5)
[1]
Measure Analysis Population Description: Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).
International normalized ratio (INR) in the field   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Ratio
Number Analyzed 36 participants 29 participants 65 participants
1.1
(1 to 1.2)
1.1
(1 to 1.1)
1.1
(1 to 1.2)
[1]
Measure Analysis Population Description: Measure Analysis Population Description: Defined as the first international normalized ratio (INR) obtained upon ED arrival. The international normalized ratio (INR) is an international standard for the prothrombin time (PT). This measures the time it takes for blood to clot. The normal range for a healthy person is 0.83–1.19.
International normalized ratio (INR) in the field >=1.3   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 29 participants 65 participants
2
   5.6%
2
   6.9%
4
   6.2%
[1]
Measure Analysis Population Description: Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).
Partial thromboplastin time (PTT) in the field   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Seconds
Number Analyzed 36 participants 28 participants 64 participants
27.1
(25 to 30)
26.9
(24.6 to 30.4)
27.1
(24.7 to 30.4)
[1]
Measure Analysis Population Description: Due to the specifics of the study (acute trauma setting) it was not always possible to obtain a blood sample in the field (accident scene).
1.Primary Outcome
Title Number of Participants That Died Within 28 Days Post Injury
Hide Description death within 28 days post injury (death of any cause except for death due to a second, clearly unrelated traumatic injury suffered after discharge)
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 65 60
Measure Type: Count of Participants
Unit of Measure: Participants
10
  15.4%
6
  10.0%
2.Secondary Outcome
Title Composite Outcome of 28-day In-hospital Mortality and Postinjury Multiple Organ Failure (MOF) Incidence
Hide Description The occurrence of in-hospital death or MOF within the first 28 days postinjury. MOF is defined using the validated Denver MOF score (Denver MOF score>3 of simultaneously obtained scores after 48 hours postinjury).
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 65 60
Measure Type: Count of Participants
Unit of Measure: Participants
14
  21.5%
7
  11.7%
3.Secondary Outcome
Title Admission Coagulopathy
Hide Description Defined as the first international normalized ratio (INR) obtained upon ED arrival. The international normalized ratio (INR) is an international standard for the prothrombin time (PT). This measures the time it takes for blood to clot. The normal range for a healthy person is 0.83–1.19. Usually, a high INR indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.
Time Frame within 30 minutes of Emergency Department (ED) arrival
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 63 58
Median (Inter-Quartile Range)
Unit of Measure: ratio
1.27
(1.11 to 1.4)
1.15
(1.08 to 1.29)
4.Secondary Outcome
Title Number of Participants With Admission Severe Coagulopathy
Hide Description Defined as international normalized ratio (INR) >1.3 obtained upon ED arrival. The international normalized ratio (INR) is an international standard for the prothrombin time (PT). This measures the time it takes for blood to clot. The normal range for a healthy person is 0.83–1.19. Usually, a high INR indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.
Time Frame within 30 minutes of Emergency Department (ED) arrival
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 63 58
Measure Type: Count of Participants
Unit of Measure: Participants
28
  44.4%
14
  24.1%
5.Secondary Outcome
Title Admission Clot Strength
Hide Description Admission clot strength will be measured by thrombelastography G-value upon ED arrival. Clot strength measured in kilodynes per square centimetre (kdyn/cm^2).
Time Frame within 30 minutes of ED arrival
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 55 51
Median (Inter-Quartile Range)
Unit of Measure: kdyne/cm^2
7.7
(6.2 to 8.9)
7.1
(5.4 to 9.7)
6.Secondary Outcome
Title Admission Acidosis
Hide Description Admission acidosis measured by lactate upon ED arrival.
Time Frame within 30 minutes of ED arrival
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 53 52
Median (Inter-Quartile Range)
Unit of Measure: mmol/L
5.5
(3.9 to 8.5)
4.9
(3.2 to 7)
7.Secondary Outcome
Title Number of Participants With Admission Severe Acidosis
Hide Description Admission severe acidosis measured by lactate>5 upon ED arrival.
Time Frame within 30 minutes of ED arrival
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 53 52
Measure Type: Count of Participants
Unit of Measure: Participants
27
  50.9%
25
  48.1%
8.Secondary Outcome
Title Admission Acidosis
Hide Description Admission acidosis will be defined by base deficit (BD) upon ED arrival.
Time Frame within 30 minutes of ED arrival
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 51 50
Median (Inter-Quartile Range)
Unit of Measure: mEq/L
9
(5.5 to 13)
8.8
(6 to 13)
9.Secondary Outcome
Title Number of Participants With Admission Severe Acidosis
Hide Description Admission severe acidosis will be defined by base deficit (BD>10) upon ED arrival.
Time Frame within 30 minutes of ED arrival
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 51 50
Measure Type: Count of Participants
Unit of Measure: Participants
21
  41.2%
22
  44.0%
10.Other Pre-specified Outcome
Title Baseline (Field) Coagulation Factor Levels
Hide Description

defined as the first coagulation factor level obtained in the field prior to intervention

Coagulation Factor Reference Ranges

F2 F5 F7 F8 F9 F11

  • % % % % % % 67.0 - 107.0 63.0 - 116.0 52.0 - 120.0 58.0 - 132.0 47.0 - 122.0 52.0 - 120.0
Time Frame after injury and prior to hospital arrival, at about 15 minutes after injury
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 34 26
Median (Inter-Quartile Range)
Unit of Measure: percentage of activity
Coagulation factor II (prothrombin)
95
(85 to 105)
98
(85 to 105)
Coagulation factor V (proaccelerin)
85
(73 to 99)
91.5
(77 to 100)
Coagulation factor VII (proconvertin)
101.5
(84 to 127)
89.5
(80 to 114)
Coagulation factor VIII (antihemophilic factor)
396.8
(273 to 476)
411.8
(353.2 to 464.6)
Coagulation factor IX (plasma thromboplastin comp)
157
(128 to 180)
160.5
(148 to 174)
Coagulation factor XI (plasma thromboplastin ante)
126.5
(106 to 153)
141.5
(100 to 168)
11.Other Pre-specified Outcome
Title Number of Participants With Abnormal Baseline (Field) Coagulation Factor XIII Level
Hide Description defined as abnormal coagulation factor XIII level obtained in the field prior to intervention
Time Frame after injury prior to hospital arrival
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 34 26
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
12.Other Pre-specified Outcome
Title Admission (First Arrival) Coagulation Factor Levels
Hide Description

defined as the first coagulation factor level obtained upon ED arrival

Coagulation Factor Reference Ranges

F2 F5 F7 F8 F9 F11

  • % % % % % % 67.0 - 107.0 63.0 - 116.0 52.0 - 120.0 58.0 - 132.0 47.0 - 122.0 52.0 - 120.0
Time Frame after injury prior to hospital arrival
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all the timepoints are available for all the patients.
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 47 41
Median (Inter-Quartile Range)
Unit of Measure: percentage of activity
Coagulation factor I (fibrinogen) Number Analyzed 39 participants 40 participants
195
(157 to 275)
222
(154.5 to 282)
Coagulation factor II (prothrombin) Number Analyzed 47 participants 41 participants
71
(57 to 88)
79
(65 to 92)
Coagulation factor V (proaccelerin) Number Analyzed 47 participants 41 participants
64
(41 to 83)
69
(52 to 91)
Coagulation factor VII (proconvertin) Number Analyzed 47 participants 41 participants
72
(56 to 94)
74
(52 to 94)
Coagulation factor VIII (antihemophilic factor) Number Analyzed 47 participants 41 participants
283.4
(168.4 to 434.2)
355.2
(279 to 462.6)
Coagulation factor IX (plasma thromboplastin comp) Number Analyzed 47 participants 41 participants
121
(87 to 142)
135
(99 to 159)
Coagulation factor XI (plasma thromboplastin ante) Number Analyzed 47 participants 41 participants
81
(58 to 127)
109
(72 to 135)
13.Other Pre-specified Outcome
Title Number of Participants With Abnormal Admission Coagulation Factor XIII (Fibrin-stabilizing Factor) Level
Hide Description defined as the first abnormal factor XIII (fibrin-stabilizing factor) level obtained upon ED arrival
Time Frame within 30 minutes of Emergency Department (ED) arrival
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 39 40
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
   5.0%
14.Other Pre-specified Outcome
Title Exploratory Analyses
Hide Description Number of participants with 24-hour mortality, adverse outcome free days and transfusions
Time Frame Hospital stay up to 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 65 60
Measure Type: Count of Participants
Unit of Measure: Participants
24-hour mortality
8
  12.3%
6
  10.0%
Acute lung injury (ALI) within 28 days
18
  27.7%
12
  20.0%
Acute lung injury (ALI) within 6 hours post-transf
19
  29.2%
22
  36.7%
MOF (Denver MOF score>3)
4
   6.2%
1
   1.7%
Haemoglobin (Hb)<7g/dL within 6 hours
3
   4.6%
2
   3.3%
Required red blood cell transf. within 24 hour
36
  55.4%
35
  58.3%
Massive transf. (>=10 units of RBC or death/6 hrs
15
  23.1%
12
  20.0%
Required plasma in first 24 h (not counting field)
29
  44.6%
26
  43.3%
Required platelets in first 24 h
15
  23.1%
11
  18.3%
Required cryoprecipitate in first 24 h
8
  12.3%
4
   6.7%
Required tranexamic acid (TXA) in first 6 h
6
   9.2%
7
  11.7%
Required factor VII infusion in first 24 h
1
   1.5%
0
   0.0%
15.Other Pre-specified Outcome
Title Exploratory Analyses.
Hide Description Adverse outcome free days
Time Frame Hospital stay up to 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 65 60
Median (Inter-Quartile Range)
Unit of Measure: days
Ventilator free days
26
(11 to 28)
26
(18 to 28)
Intensive care unit (ICU) free days
23
(7 to 26)
24
(16.5 to 26)
16.Other Pre-specified Outcome
Title Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock
Hide Description Mortality, adverse outcome-free days and transfusions in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater
Time Frame Hospital stay up to 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 21 27
Measure Type: Count of Participants
Unit of Measure: Participants
28-day mortality
0
   0.0%
2
   7.4%
Death or multiple organ failure within 28 days
0
   0.0%
2
   7.4%
Acute lung injury (ALI) within 28 days
8
  38.1%
12
  44.4%
Acute lung injury (ALI) within 6 h post-transfusio
5
  23.8%
8
  29.6%
MOF (Denver MOF score>3)
0
   0.0%
0
   0.0%
Haemoglobin (Hb)<7g/dL within 6 hours
1
   4.8%
0
   0.0%
Required red blood cell transfusion within 24 h
7
  33.3%
14
  51.9%
Massive transf. (>=10 units of RBC or death/6 hrs
0
   0.0%
5
  18.5%
Required plasma in first 24 h (not counting field)
3
  14.3%
9
  33.3%
Required platelets in first 24 h
1
   4.8%
6
  22.2%
Required cryoprecipitate in first 24 h
0
   0.0%
2
   7.4%
Required tranexamic acid (TXA) in first 6 h
2
   9.5%
2
   7.4%
Required factor VII infusion in first 24 h
0
   0.0%
0
   0.0%
17.Other Pre-specified Outcome
Title Adverse Outcome-free Days in a Sub-group With Less Severe Hemorrhagic Shock
Hide Description Adverse outcome-free days in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater
Time Frame Hospital stay up to 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 21 27
Median (Inter-Quartile Range)
Unit of Measure: days
Ventilator free days
27
(22 to 28)
26
(17 to 28)
Intensive care unit (ICU) free days
24
(22 to 27)
25
(12 to 26)
18.Other Pre-specified Outcome
Title Level of Haemoglobin (Hb) in a Sub-group With Less Severe Hemorrhagic Shock
Hide Description Level of Haemoglobin (Hb) in g/dL in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater
Time Frame Hospital stay up to 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 21 27
Median (Inter-Quartile Range)
Unit of Measure: g/dL
Admission (first arrival) Haemoglobin (Hb)
14.4
(13 to 15.2)
13.5
(12 to 14.7)
Lowest Haemoglobin (Hb) in first 6 hours
11.6
(10.1 to 13.6)
11.4
(9.3 to 13)
19.Other Pre-specified Outcome
Title Blood Product Transfusion in a Sub-group With Less Severe Hemorrhagic Shock
Hide Description Transfusions of blood products in units in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater
Time Frame Hospital stay up to 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 21 27
Median (Inter-Quartile Range)
Unit of Measure: units
Red blood cell (RBC) transfusion in 24 h
0
(0 to 2)
1
(0 to 8)
Plasma transfused in 24h (excluding pre-admission)
0
(0 to 0)
0
(0 to 2)
Platelets transfused in 24 h
0
(0 to 0)
0
(0 to 0)
Cryoprecipitate transfused in 24 h
0
(0 to 0)
0
(0 to 0)
20.Other Pre-specified Outcome
Title Time to Admission and First Blood Transfusion in a Sub-group With Less Severe Hemorrhagic Shock
Hide Description Time to Admission and First Blood Transfusion in minutes in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater
Time Frame Hospital stay up to 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 21 27
Median (Inter-Quartile Range)
Unit of Measure: minutes
Time from injury to ED admission
30
(25 to 40)
25
(19 to 32)
Time from injury to first unit of RBC
119.5
(44.5 to 159.5)
39
(24 to 56)
21.Other Pre-specified Outcome
Title Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock
Hide Description Mortality, adverse outcome-free days and transfusions in the patients with initial systolic blood pressure (SBP) <=70 mmHg
Time Frame Hospital stay up to 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 44 33
Measure Type: Count of Participants
Unit of Measure: Participants
28-day mortality
10
  22.7%
4
  12.1%
Death or multiple organ failure within 28 days
14
  31.8%
5
  15.2%
24-hour mortality
8
  18.2%
4
  12.1%
Acute lung injury (ALI) within 28 days
20
  45.5%
18
  54.5%
Acute lung injury (ALI) within 6 h post-transfusio
14
  31.8%
14
  42.4%
MOF (Denver MOF score>3)
4
   9.1%
1
   3.0%
Haemoglobin (Hb)<7g/dL within 6 hours
2
   4.5%
2
   6.1%
Required red blood cell transfusion within 24 h
29
  65.9%
21
  63.6%
Massive transf. (>=10 units of RBC or death/6 hrs
15
  34.1%
7
  21.2%
Required plasma in first 24 h (not counting field)
26
  59.1%
17
  51.5%
Required platelets in first 24 h
12
  27.3%
4
  12.1%
Required cryoprecipitate in first 24 h
8
  18.2%
2
   6.1%
Required tranexamic acid (TXA) in first 6 h
4
   9.1%
5
  15.2%
Required factor VII infusion in first 24 h
1
   2.3%
0
   0.0%
22.Other Pre-specified Outcome
Title Number of Adverse Outcome Free Days in a Sub-group With Severe Hemorrhagic Shock
Hide Description Adverse outcome-free days in the patients with initial systolic blood pressure (SBP) <=70 mmHg
Time Frame Hospital stay up to 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all the timepoints are available for all the patients.
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 44 33
Median (Inter-Quartile Range)
Unit of Measure: days
Ventilator free days
24.5
(0 to 27.5)
26
(22 to 28)
Intensive care unit (ICU) free days
20
(0 to 26)
23
(19 to 25)
23.Other Pre-specified Outcome
Title Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI)
Hide Description Number of participants with mortality, adverse outcome-free days and transfusions in the patients with no severe traumatic brain injury (TBI) is defined as Abbreviated Injury Score (AIS) for Head/Neck >=3.
Time Frame Hospital stay up to 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 52 45
Measure Type: Count of Participants
Unit of Measure: Participants
28-day mortality
6
  11.5%
5
  11.1%
Death or multiple organ failure within 28 days
9
  17.3%
6
  13.3%
24-hour mortality
6
  11.5%
5
  11.1%
Acute lung injury (ALI) within 28 days
20
  38.5%
21
  46.7%
Possible transfusion associated acute lung injury
12
  23.1%
16
  35.6%
Required red blood cell transfusion within 72 h
28
  53.8%
26
  57.8%
Massive transf. (>=10 units of RBC or death/6 hrs
10
  19.2%
10
  22.2%
Required tranexamic acid (TXA) in first 6 h
5
   9.6%
6
  13.3%
Required factor VII infusion in first 24 h
1
   1.9%
0
   0.0%
24.Other Pre-specified Outcome
Title Exploratory Analyses in a Sub-group With Severe Traumatic Brain Injury (TBI)
Hide Description Number of participants with 28-day mortality. Traumatic brain injury (TBI) is defined as Abbreviated Injury Score (AIS) for Head/Neck >=3.
Time Frame Hospital stay up to 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 13 15
Measure Type: Count of Participants
Unit of Measure: Participants
4
  30.8%
1
   6.7%
25.Other Pre-specified Outcome
Title Severe Adverse Events (SAE)
Hide Description Number of participants with severe adverse events (SAE)
Time Frame Hospital stay up to day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 75 69
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAEs
34
  45.3%
24
  34.8%
Death
12
  16.0%
6
   8.7%
Infections
14
  18.7%
13
  18.8%
Thromboembolic events
4
   5.3%
2
   2.9%
Non-infectious and non-thromboembolic events
15
  20.0%
11
  15.9%
MOF (Denver MOF score>3)
5
   6.7%
1
   1.4%
Organ failure (not MOF)
15
  20.0%
13
  18.8%
26.Other Pre-specified Outcome
Title Haemoglobin (Hb) Level in a Sub-group With Severe Hemorrhagic Shock
Hide Description Haemoglobin (Hb) level in the patients with initial systolic blood pressure (SBP) <=70 mmHg
Time Frame Hospital stay up to 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all the timepoints are available for all the patients.
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 44 33
Median (Inter-Quartile Range)
Unit of Measure: g/dL
Admission (first arrival) Haemoglobin (Hb)
11.8
(10.5 to 13.8)
13.2
(11.8 to 14.6)
Lowest Haemoglobin (Hb) in first 6 hours
11.3
(8.7 to 12.4)
10.8
(8.7 to 12.5)
27.Other Pre-specified Outcome
Title Blood Product Transfusion in a Sub-group With Severe Hemorrhagic Shock
Hide Description Number of blood products transfused in units in the patients with initial systolic blood pressure (SBP) <=70 mmHg
Time Frame Hospital stay up to 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all the timepoints are available for all the patients.
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 44 33
Median (Inter-Quartile Range)
Unit of Measure: units
Red blood cell (RBC) transfusion in 24 h
3.5
(0 to 13.5)
3
(0 to 8)
Plasma transfused in 24h (excluding pre-admission)
1
(0 to 5)
1
(0 to 3)
Platelets transfused in 24 h
0
(0 to 1)
0
(0 to 0)
Cryoprecipitate transfused in 24 h
0
(0 to 0)
0
(0 to 0)
28.Other Pre-specified Outcome
Title Time to Admission and First Blood Transfusion in a Sub-group With Severe Hemorrhagic Shock
Hide Description Time to Admission and First Blood Transfusion in the patients with initial systolic blood pressure (SBP) <=70 mmHg
Time Frame Hospital stay up to 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all the timepoints are available for all the patients.
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 44 33
Median (Inter-Quartile Range)
Unit of Measure: minutes
Time from injury to ED admission
28
(21 to 33)
23
(19 to 28)
Time from injury to first unit of RBC
48
(32 to 59)
36
(30 to 44)
29.Other Pre-specified Outcome
Title Haemoglobin (Hb) Level
Hide Description Haemoglobin (Hb) level in g/dL units.
Time Frame Hospital stay up to 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 65 60
Median (Inter-Quartile Range)
Unit of Measure: g/dL
Admission (first arrival) Haemoglobin (Hb)
12.6
(11.3 to 14.7)
13.5
(11.9 to 14.7)
Lowest Haemoglobin (Hb) in first 6 hours
11.3
(9.6 to 12.6)
11
(9.1 to 12.8)
30.Other Pre-specified Outcome
Title Number of Blood Products Transfused.
Hide Description Number of blood products transfused in units.
Time Frame Hospital stay up to 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 65 60
Median (Inter-Quartile Range)
Unit of Measure: units
Red blood cell (RBC) transfusion in 24 h
2
(0 to 8)
1.5
(0 to 8)
Plasma transfused in 24h (excluding pre-admission)
0
(0 to 4)
0
(0 to 3)
Platelets transfused in 24 h
0
(0 to 0)
0
(0 to 0)
Cryoprecipitate transfused in 24 h
0
(0 to 0)
0
(0 to 0)
31.Other Pre-specified Outcome
Title Time to Admission and First Blood Transfusion
Hide Description Time to admission and first blood product transfusion in minutes.
Time Frame Hospital stay up to 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 65 60
Median (Inter-Quartile Range)
Unit of Measure: minutes
Time from injury to ED admission
28
(22 to 34)
24
(19 to 31)
Time from injury to first unit of RBC
46.5
(32 to 55.5)
37
(24 to 46)
Time from ED admission to first unit of RBC
16
(7 to 28)
10
(4 to 18)
Time to first plasma (including pre-admission)
24
(20 to 31.5)
58.5
(40 to 115)
Time from admission to first platelet transfused
130
(91 to 222)
88
(56 to 166)
32.Post-Hoc Outcome
Title Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Hide Description Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG) activated clotting time (ACT).
Time Frame after injury and prior to hospital arrival, at about 15 minutes after injury
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 43 37
Median (Inter-Quartile Range)
Unit of Measure: second
121
(113 to 128)
121
(113 to 128)
33.Post-Hoc Outcome
Title Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Hide Description Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) activated clotting time (ACT) in seconds.
Time Frame post-intervention and upon ED arrival
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 55 51
Median (Inter-Quartile Range)
Unit of Measure: second
128
(113 to 136)
121
(113 to 136)
34.Post-Hoc Outcome
Title Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Hide Description Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG) angle in degrees.
Time Frame after injury and prior to hospital arrival, at about 15 minutes after injury
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 43 37
Median (Inter-Quartile Range)
Unit of Measure: degrees
70.6
(66.9 to 75.6)
70.6
(66.1 to 74.3)
35.Post-Hoc Outcome
Title Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Hide Description Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG) maximum amplitude (MA).
Time Frame after injury and prior to hospital arrival, at about 15 minutes after injury
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 43 37
Median (Inter-Quartile Range)
Unit of Measure: millimeter (mm)
62
(57.5 to 68)
63.5
(58 to 67)
36.Post-Hoc Outcome
Title Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Hide Description Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG). Clot strength measured in kilodynes per square centimetre (kdyn/cm^2).
Time Frame after injury and prior to hospital arrival, at about 15 minutes after injury
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 43 37
Median (Inter-Quartile Range)
Unit of Measure: kdyn/cm^2
8.2
(6.8 to 10.6)
8.7
(6.9 to 10.2)
37.Post-Hoc Outcome
Title Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Hide Description Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG). Percentage of clot lysis 30 minutes after maximal amplitude (MA) value is finalized.
Time Frame after injury and prior to hospital arrival, at about 15 minutes after injury
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 43 37
Median (Inter-Quartile Range)
Unit of Measure: percentage of clot lysed at 30 minutes
2.2
(1 to 3.7)
1.8
(0.9 to 3.7)
38.Post-Hoc Outcome
Title Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Hide Description Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) angle measured in degrees.
Time Frame post-intervention and upon ED arrival
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 55 51
Median (Inter-Quartile Range)
Unit of Measure: degree
60.5
(55.5 to 64)
58.5
(52 to 66)
39.Post-Hoc Outcome
Title Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Hide Description Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) maximal amplitude (MA).
Time Frame post-intervention and upon ED arrival
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 55 51
Median (Inter-Quartile Range)
Unit of Measure: millimeter (mm)
70.9
(66.1 to 76.1)
69.3
(63.2 to 74.4)
40.Post-Hoc Outcome
Title Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Hide Description Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) clot strength measures by G value in kilodynes per square centimetre (kdyn/cm^2).
Time Frame post-intervention and upon ED arrival
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 55 51
Median (Inter-Quartile Range)
Unit of Measure: kdyn/cm^2
7.7
(6.2 to 8.9)
7.1
(5.4 to 9.7)
41.Post-Hoc Outcome
Title Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Hide Description Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) clot lysis 30 minutes after the maximal amplitude (MA) was finalized.
Time Frame post-intervention and upon ED arrival
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasma Standard
Hide Arm/Group Description:

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Overall Number of Participants Analyzed 55 51
Median (Inter-Quartile Range)
Unit of Measure: percentage of clot lysed at 30 minutes
1.3
(0.3 to 2.6)
1.6
(0.7 to 3.1)
Time Frame Hospital stay up to 28 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Plasma Standard
Hide Arm/Group Description

If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm.

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

All-Cause Mortality
Plasma Standard
Affected / at Risk (%) Affected / at Risk (%)
Total   12/75 (16.00%)      6/69 (8.70%)    
Show Serious Adverse Events Hide Serious Adverse Events
Plasma Standard
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/75 (45.33%)      24/69 (34.78%)    
Cardiac disorders     
Cardiac  [1]  7/75 (9.33%)  7 6/69 (8.70%)  6
Endocrine disorders     
Adrenal insufficiency   1/75 (1.33%)  1 0/69 (0.00%)  0
Gastrointestinal disorders     
GI bleed  [2]  2/75 (2.67%)  2 0/69 (0.00%)  0
Hepatobiliary disorders     
Liver failure  [3]  4/75 (5.33%)  4 4/69 (5.80%)  4
Infections and infestations     
Infections   14/75 (18.67%)  23 13/69 (18.84%)  20
Renal and urinary disorders     
Acute kidney injury (AKI)  [4]  5/75 (6.67%)  5 6/69 (8.70%)  6
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome (ARDS)  [5]  20/75 (26.67%)  20 14/69 (20.29%)  14
Skin and subcutaneous tissue disorders     
Hematoma  [6]  1/75 (1.33%)  1 0/69 (0.00%)  0
Surgical and medical procedures     
Hemorrhage  [7]  2/75 (2.67%)  2 0/69 (0.00%)  0
Vascular disorders     
DVTs and PEs  [8]  4/75 (5.33%)  4 2/69 (2.90%)  2
Indicates events were collected by systematic assessment
[1]
Organ failure, atrial fibrillation and ventricular tachycardia
[2]
Gastrointestinal bleeding and abdominal compartment syndrome
[3]
Liver failure and bile duct leak
[4]
Acute kidney injury (AKI), kidney failure and renal artery pseudoaneurysm.
[5]
Acute respiratory distress syndrome (ARDS) and lung failure
[6]
Pre-sacral hematoma
[7]
Delayed hemorrhage from surgical site and torn suture
[8]
Deep venous thrombosis (DVT), pulmonary embolism (PE) and pulmonary infarction (PI).
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Plasma Standard
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/75 (6.67%)      2/69 (2.90%)    
Musculoskeletal and connective tissue disorders     
Rhabdomyolysis   1/75 (1.33%)  0/69 (0.00%) 
Nervous system disorders     
Facial paralysis   1/75 (1.33%)  0/69 (0.00%) 
Psychiatric disorders     
Intensive Care Unit (ICU) delirium   3/75 (4.00%)  2/69 (2.90%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Ernest E. Moore
Organization: Denver Health Medical Center
Phone: 303.602.1820
Responsible Party: Ernest E. Moore, MD, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01838863     History of Changes
Other Study ID Numbers: COMIRB# 12-1349
W81XWH1220028 ( Other Grant/Funding Number: Department of Defense TATRC )
First Submitted: April 22, 2013
First Posted: April 24, 2013
Results First Submitted: March 22, 2018
Results First Posted: July 18, 2018
Last Update Posted: July 18, 2018