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Comparison of Rapid Thrombelastography and Conventional Coagulation Testing for Haemostatic Resuscitation in Trauma

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ClinicalTrials.gov Identifier: NCT01536496
Recruitment Status : Completed
First Posted : February 22, 2012
Results First Posted : February 17, 2016
Last Update Posted : February 17, 2016
Sponsor:
Collaborator:
Haemonetics Corporation
Information provided by (Responsible Party):
Ernest Moore, Denver Health and Hospital Authority

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Acute Coagulopathy
Interventions Biological: Blood product transfusion based on conventional coagulation tests.
Biological: Blood product transfusion based on rapid thrombelastography (r-TEG) results.
Enrollment 114

Recruitment Details The first patient was enrolled on 09/25/2010 and the last one was enrolled on 03/21/2014. The patients were enrolled when they met the inclusion criteria for the study, which were the criteria that activate the massive transfusion protocol. Enrollment occured upon arrival either in Emergency Room or in Operating Room.
Pre-assignment Details  
Arm/Group Title Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Hide Arm/Group Description

Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.

Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on rapid thrombelastography (r-TEG) results.:

Period Title: Overall Study
Started 57 57
Completed 55 56
Not Completed 2 1
Arm/Group Title Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG) Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 55 56 111
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 55 participants 56 participants 111 participants
38
(25 to 55)
41
(28 to 54)
39
(28 to 55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 56 participants 111 participants
Female
14
  25.5%
19
  33.9%
33
  29.7%
Male
41
  74.5%
37
  66.1%
78
  70.3%
Injury Severity Score (ISS)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Scores on a scale
Number Analyzed 55 participants 56 participants 111 participants
33
(25 to 43)
29.5
(23 to 41)
30
(24 to 43)
[1]
Measure Description: 0 to 75, higher score means worse outcome
Base Deficit (BD)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mEq/L
Number Analyzed 55 participants 56 participants 111 participants
13.7
(9 to 18)
11.0
(9 to 16)
12.0
(9 to 18)
[1]
Measure Description: Base deficit refers to lack of bases in the blood. Bases are crucial in sustaining the acid-base homeostasis in the human body. Base deficit is an indicator of metabolic component of blood pH, as opposed to carbon dioxide, which is an indicator of respiratory component of blood pH. Base deficit outside of normal values (-2 to 2 mEq/L) usually means a shift in homeostasis towards acids or metabolic acidosis. More negative values are indicative of more profound disturbance in homeostasis.
International Normalized Ratio (INR)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 55 participants 56 participants 111 participants
1.46
(1.2 to 2.3)
1.45
(1.2 to 1.7)
1.45
(1.2 to 1.9)
[1]
Measure Description: The reference range of the local clinical laboratory is 0.83-1.19. A high INR indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.
Platelet count   [1] 
Median (Inter-Quartile Range)
Unit of measure:  k/uL
Number Analyzed 55 participants 56 participants 111 participants
214
(165 to 279)
214
(145 to 318)
214
(150 to 291)
[1]
Measure Description: The reference range of the local clinical laboratory is 150-400 k/uL.
Fibrinogen   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 55 participants 56 participants 111 participants
113
(68 to 139)
132
(94 to 240)
122
(75 to 201)
[1]
Measure Description: The reference range of the local clinical laboratory is 200.0-485.0 mg/dL.
D-dimer   [1] 
Median (Inter-Quartile Range)
Unit of measure:  ug/mL
Number Analyzed 55 participants 56 participants 111 participants
12.9
(6 to 20)
10.3
(2 to 20)
11.1
(4 to 20)
[1]
Measure Description: The reference range of the local clinical laboratory is <0.50 ug/mL.
TEG ACT (activated clotting time)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Seconds
Number Analyzed 55 participants 56 participants 111 participants
128
(113 to 278)
128
(113 to 140)
128
(113 to 195)
[1]
Measure Description: The reference range of the local clinical laboratory is 78.0-110.0.
TEG Angle   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Degrees
Number Analyzed 55 participants 56 participants 111 participants
50.9
(28 to 69)
52.3
(30 to 70)
51.5
(29 to 69)
[1]
Measure Description: The reference range of the local clinical laboratory is 66.0-82.0 degrees.
TEG MA (maximal amplitude)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Mm
Number Analyzed 55 participants 56 participants 111 participants
47.5
(34 to 53)
53.9
(28 to 63)
50.9
(31 to 60)
[1]
Measure Description: The reference range of the local clinical laboratory is 54.0-72.0 mm.
TEG LY30   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Percent of clot lysis at 30 minutes
Number Analyzed 55 participants 56 participants 111 participants
0.5
(0 to 4.4)
1.2
(0.1 to 4.2)
0.9
(0 to 4.3)
[1]
Measure Description: The reference range of the local clinical laboratory is 0.0-7.4%. Percent of clot lysis 30 minutes after maximal amplitude (MA) was finalized.
1.Primary Outcome
Title 28 Day In-hospital Mortality
Hide Description [Not Specified]
Time Frame 28 days in hospital
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Hide Arm/Group Description:

Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.

Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on rapid thrombelastography (r-TEG) results.:

Overall Number of Participants Analyzed 55 56
Measure Type: Number
Unit of Measure: participants
20 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control (INR, PTT, Fibrinogen, D-dimer), Test (r-TEG)
Comments Chi-square test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Deaths Specified as Early Mortality (<6 Hours Post-injury) and Delayed Mortality (6-24 Hours Post-injury).
Hide Description [Not Specified]
Time Frame Within 24 hours post-injury.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Hide Arm/Group Description:

Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.

Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on rapid thrombelastography (r-TEG) results.:

Overall Number of Participants Analyzed 55 56
Measure Type: Number
Unit of Measure: deaths
Number of deaths <6 hours from injury 12 4
Number of deaths 6-24 hours from injury 8 7
3.Secondary Outcome
Title Deaths Related to Coagulopathic Bleeding Based Upon Clinical Impressions of the Treating Surgeons and Review of Operative Records and Outcome (Hours Since Injury).
Hide Description [Not Specified]
Time Frame Up to 28 days post-injury.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Hide Arm/Group Description:

Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.

Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on rapid thrombelastography (r-TEG) results.:

Overall Number of Participants Analyzed 55 56
Measure Type: Number
Unit of Measure: deaths
11 5
4.Secondary Outcome
Title Time to Death From Injury in Hours.
Hide Description [Not Specified]
Time Frame From time of injury to 28th day of hospitalization.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Hide Arm/Group Description:

Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.

Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on rapid thrombelastography (r-TEG) results.:

Overall Number of Participants Analyzed 20 11
Median (Inter-Quartile Range)
Unit of Measure: hours
4.2
(1.2 to 9.9)
10.4
(4.5 to 200.3)
5.Secondary Outcome
Title Change in INR Test Results.
Hide Description A high International Normalized Ratio (INR) indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.
Time Frame Within first 6 hours post-injury, 12 and 24 hours post-injury.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Hide Arm/Group Description:

Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.

Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on rapid thrombelastography (r-TEG) results.:

Overall Number of Participants Analyzed 55 56
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
INR at 6 hours
1.5
(1.3 to 2.2)
1.8
(1.3 to 2.1)
INR at 12 hours
1.4
(1.2 to 1.6)
1.4
(1.3 to 1.9)
INR at 24 hours
1.5
(1.4 to 1.7)
1.4
(1.3 to 2)
6.Secondary Outcome
Title Change in Fibrinogen Test Results.
Hide Description [Not Specified]
Time Frame Within first 6 hours post-injury, 12 and 24 hours post-injury.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (INR, Fibrinogen, D-dimer) Test (r-TEG)
Hide Arm/Group Description:

Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.

Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on rapid thrombelastography (r-TEG) results.:

Overall Number of Participants Analyzed 55 56
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
fibrinogen at 6 hours
161.5
(112 to 175)
153
(111 to 180)
fibrinogen at 12 hours
185.5
(159 to 232)
159
(111 to 214)
fibrinogen at 24 hours
233
(218 to 256)
203
(150 to 266)
7.Secondary Outcome
Title Change in Platelet Count Test Results.
Hide Description [Not Specified]
Time Frame Within first 6 hours post-injury, 12 and 24 hours post-injury.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Hide Arm/Group Description:

Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.

Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on rapid thrombelastography (r-TEG) results.:

Overall Number of Participants Analyzed 55 56
Median (Inter-Quartile Range)
Unit of Measure: k/uL
platelet count at 6 hours
90
(60 to 144)
100
(89 to 140)
platelet count at 12 hours
116
(75 to 157)
110
(90 to 139)
platelet count at 24 hours
96.5
(72 to 128)
109
(91 to 130)
8.Secondary Outcome
Title Change in D-dimer Test Results.
Hide Description [Not Specified]
Time Frame Within first 6 hours post-injury, 12 and 24 hours post-injury.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Hide Arm/Group Description:

Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.

Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on rapid thrombelastography (r-TEG) results.:

Overall Number of Participants Analyzed 55 56
Median (Inter-Quartile Range)
Unit of Measure: ug/mL
D-dimer at 6 hours
8.3
(1 to 15)
8.7
(2 to 13)
D-dimer at 12 hours
8
(2 to 13)
6.4
(3 to 13)
D-dimer at 24 hours
5.4
(2 to 13)
5
(3 to 13)
9.Secondary Outcome
Title Change in r-TEG ACT (Activated Clotting Time) Test Results.
Hide Description [Not Specified]
Time Frame Within first 6 hours post-injury, 12 and 24 hours post-injury.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Hide Arm/Group Description:

Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.

Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on rapid thrombelastography (r-TEG) results.:

Overall Number of Participants Analyzed 55 56
Median (Inter-Quartile Range)
Unit of Measure: seconds
r-TEG ACT at 6 hours
124
(113 to 142)
121
(117 to 144)
r-TEG ACT at 12 hours
128
(121 to 144)
121
(113 to 140)
r-TEG ACT at 24 hours
128
(121 to 128)
128
(121 to 136)
10.Secondary Outcome
Title Change in r-TEG Angle Test Results.
Hide Description [Not Specified]
Time Frame Within first 6 hours post-injury, 12 and 24 hours post-injury.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Hide Arm/Group Description:

Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.

Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on rapid thrombelastography (r-TEG) results.:

Overall Number of Participants Analyzed 55 56
Median (Inter-Quartile Range)
Unit of Measure: degrees
r-TEG Angle at 6 hours
70.8
(64 to 72)
68.2
(60 to 73)
r-TEG Angle at 12 hours
68.5
(60 to 70)
65.5
(57 to 73)
r-TEG Angle at 24 hours
69.1
(61 to 71)
71.3
(64 to 74)
11.Secondary Outcome
Title Change in r-TEG Maximal Amplitude (MA) Test Results.
Hide Description [Not Specified]
Time Frame Within first 6 hours post-injury, 12 and 24 hours post-injury.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Hide Arm/Group Description:

Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.

Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on rapid thrombelastography (r-TEG) results.:

Overall Number of Participants Analyzed 55 56
Median (Inter-Quartile Range)
Unit of Measure: mm
r-TEG MA at 6 hours
53.8
(49 to 59)
51
(46 to 57)
r-TEG MA at 12 hours
55
(52 to 57)
56.9
(49 to 58)
r-TEG MA at 24 hours
56.5
(46 to 62)
56.9
(54 to 61)
12.Secondary Outcome
Title Change in r-TEG LY30 Test Results.
Hide Description [Not Specified]
Time Frame Within first 6 hours post-injury, 12 and 24 hours post-injury.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Hide Arm/Group Description:

Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.

Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on rapid thrombelastography (r-TEG) results.:

Overall Number of Participants Analyzed 55 56
Median (Inter-Quartile Range)
Unit of Measure: percent of clot lysis at 30 min.
r-TEG LY30 at 6 hours
0
(0 to 0)
0
(0 to 1.5)
r-TEG LY30 at 12 hours
0.3
(0 to 0.5)
0.1
(0.1 to 1.5)
r-TEG LY30 at 24 hours
0.7
(0.2 to 1.6)
0.7
(0.7 to 1.7)
13.Secondary Outcome
Title Composition and Quantity of Blood Products Transfused at 24 Hours Post-injury
Hide Description Amount of blood product (red blood cells, plasma, cryoprecipitate and platelets) in units.
Time Frame 24 hours post-injury
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Hide Arm/Group Description:

Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.

Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on rapid thrombelastography (r-TEG) results.:

Overall Number of Participants Analyzed 55 56
Median (Inter-Quartile Range)
Unit of Measure: units
Red blood cell units
11.0
(6 to 16)
9.5
(5 to 16)
Plasma units
6.0
(4 to 9)
5
(3 to 9)
Cryoprecipitate units
1.0
(0 to 2)
0
(0 to 2)
Platelet units
1
(0 to 2)
1
(0 to 2)
14.Secondary Outcome
Title Length of Stay (Days) in the Surgical Intensive Care Unit (SICU) Reported as ICU-free Days and Number of Days on the Ventialator Reported as Ventilator Free Days.
Hide Description [Not Specified]
Time Frame 28 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Hide Arm/Group Description:

Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.

Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on rapid thrombelastography (r-TEG) results.:

Overall Number of Participants Analyzed 55 56
Median (Inter-Quartile Range)
Unit of Measure: days
ICU-free days.
8.5
(0 to 19.5)
16
(0 to 22)
Ventilator-free days.
13
(0 to 22)
18
(0 to 25)
15.Secondary Outcome
Title Number of Participants With Multiple Organ Failure (MOF) During This Hospitalization.
Hide Description Multiple Organ Failure (MOF) score (Denver method) was calculated for the participants. This score rates the dysfunction of four organ systems (pulmonary, renal, hepatic, and cardiac), which are evaluated daily throughout the patient's intensive care unit stay and graded on a scale from 0 to 3, with the total score ranging from 0-12. Higher values on the score represent worse outcome. Participants with score above 3 were considered to have MOF.
Time Frame Up to 30 days post-injury.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Hide Arm/Group Description:

Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.

Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on rapid thrombelastography (r-TEG) results.:

Overall Number of Participants Analyzed 55 56
Measure Type: Number
Unit of Measure: participants
3 2
Time Frame Up to 28 days of hospitalization.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Hide Arm/Group Description

Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.

Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Blood product transfusion based on rapid thrombelastography (r-TEG) results.:

All-Cause Mortality
Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/55 (0.00%)      0/56 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control (INR, PTT, Fibrinogen, D-dimer) Test (r-TEG)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   55/55 (100.00%)      56/56 (100.00%)    
Blood and lymphatic system disorders     
Abnormal laboratory finding [1]  55/55 (100.00%)  55 56/56 (100.00%)  56
[1]
All subjects in this trial had abnormal lab results (coagulation, hematology, etc.) and as such were reported as adverse events to local IRB.
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: Ernest E. Moore
Organization: Denver Health Medical Center
Phone: 303.602.1817
Responsible Party: Ernest Moore, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01536496     History of Changes
Other Study ID Numbers: COMIRB # 10-0477
First Submitted: July 19, 2011
First Posted: February 22, 2012
Results First Submitted: June 16, 2015
Results First Posted: February 17, 2016
Last Update Posted: February 17, 2016