ClinicalTrials.gov
ClinicalTrials.gov Menu

Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01545232
Recruitment Status : Completed
First Posted : March 6, 2012
Results First Posted : June 3, 2015
Last Update Posted : November 30, 2017
Sponsor:
Collaborators:
United States Department of Defense
National Heart, Lung, and Blood Institute (NHLBI)
Resuscitation Outcomes Consortium
Defence Research and Development Canada
Information provided by (Responsible Party):
John Holcomb, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Trauma
Interventions Biological: 1:1:1 Blood Transfusion Ratio
Biological: 1:1:2 Blood Transfusion Ratio
Enrollment 680
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1:1:1 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio
Hide Arm/Group Description 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol. 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Period Title: Overall Study
Started 338 342
Completed 338 342
Not Completed 0 0
Arm/Group Title 1:1:1 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio Total
Hide Arm/Group Description 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol. 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol. Total of all reporting groups
Overall Number of Baseline Participants 338 342 680
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 338 participants 342 participants 680 participants
338 342 680
[1]
Measure Description: 15 years of age or older
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 338 participants 342 participants 680 participants
Female
75
  22.2%
59
  17.3%
134
  19.7%
Male
263
  77.8%
283
  82.7%
546
  80.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 338 participants 342 participants 680 participants
Hispanic or Latino
61
  18.0%
59
  17.3%
120
  17.6%
Not Hispanic or Latino
277
  82.0%
283
  82.7%
560
  82.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 338 participants 342 participants 680 participants
American Indian or Alaska Native
6
   1.8%
2
   0.6%
8
   1.2%
Asian
21
   6.2%
8
   2.3%
29
   4.3%
Native Hawaiian or Other Pacific Islander
3
   0.9%
1
   0.3%
4
   0.6%
Black or African American
93
  27.5%
93
  27.2%
186
  27.4%
White
210
  62.1%
224
  65.5%
434
  63.8%
More than one race
2
   0.6%
0
   0.0%
2
   0.3%
Unknown or Not Reported
3
   0.9%
14
   4.1%
17
   2.5%
1.Primary Outcome
Title 24-hour Mortality
Hide Description [Not Specified]
Time Frame First 24 hours after ED admission
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who were randomized to each group
Arm/Group Title 1:1:1 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio
Hide Arm/Group Description:
1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Overall Number of Participants Analyzed 338 342
Measure Type: Number
Unit of Measure: participants
43 58
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1:1 Blood Transfusion Ratio, 1:1:2 Blood Transfusion Ratio
Comments Initial sample size (580) planned to detect a clinically meaningful 10% difference in 24-hour mortality (11% vs. 21%) supported by prior data. Data Safety Monitoring Board (DSMB) increased sample size to 680 according to trial’s adaptive design. With 680 pts. & given the final observed mortality proportions in 1:1:1 group, PROPPR had 95% power to detect the pre-specified 10% difference at 24 hours if such differences existed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Mantel Haenszel
Comments The critical level for significance (p<0.044) was adjusted for two interim analyses, and all tests were conducted using two-sided tests.
Method of Estimation Estimation Parameter Adjusted Relative Risk
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.52 to 1.08
Estimation Comments [Not Specified]
2.Primary Outcome
Title 30-day Mortality
Hide Description [Not Specified]
Time Frame First 30 days after ED admission
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of subjects enrolled into each group.
Arm/Group Title 1:1:1 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio
Hide Arm/Group Description:
1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Overall Number of Participants Analyzed 338 342
Measure Type: Number
Unit of Measure: participants
75 89
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1:1 Blood Transfusion Ratio, 1:1:2 Blood Transfusion Ratio
Comments Initial sample size of 580 planned to detect clinically meaningful a 12% difference in 30-day mortality (23% vs. 35%),supported by prior data. DSMB increased sample size to 680 according to trial’s adaptive design. With 680 patients & given final observed mortality proportions in the 1:1:1 group, PROPPR had 92% power to detect the pre-specified 12% difference at 30 days, if such differences existed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method Mantel Haenszel
Comments The critical level for significance (p<0.044) was adjusted for two interim analyses, and all tests were conducted using two-sided tests.
Method of Estimation Estimation Parameter Adjusted Relative Risk
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.65 to 1.12
Estimation Comments [Not Specified]
3.Primary Outcome
Title Coagulation and Inflammatory Phenotypes at Emergency Department Admission and Over Time.
Hide Description [Not Specified]
Time Frame 72 hours
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Hospital Free Days
Hide Description [Not Specified]
Time Frame first 30 days after ED admission
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of hospital free days for each group.
Arm/Group Title 1:1:1 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio
Hide Arm/Group Description:
1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Overall Number of Participants Analyzed 338 342
Median (Inter-Quartile Range)
Unit of Measure: days
1
(0 to 17)
0
(0 to 16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1:1 Blood Transfusion Ratio, 1:1:2 Blood Transfusion Ratio
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method van Elteren's test for medians
Comments [Not Specified]
5.Secondary Outcome
Title Time to Hemostasis
Hide Description Time to hemostasis refers to the time that the subject achieved hemorrhage control (anatomic hemostasis and resuscitation complete)following emergency department (ED) arrival.
Time Frame ED admission to hospital discharge or 30 days, whichever comes first
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Time to anatomic hemostasis
Arm/Group Title 1:1:1 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio
Hide Arm/Group Description:
1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Overall Number of Participants Analyzed 338 342
Median (Inter-Quartile Range)
Unit of Measure: minutes
105
(64 to 179)
100
(56 to 181)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1:1 Blood Transfusion Ratio, 1:1:2 Blood Transfusion Ratio
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method van Elteren's test for medians
Comments [Not Specified]
6.Secondary Outcome
Title Amount of Randomized Blood Products Given to Hemostasis
Hide Description [Not Specified]
Time Frame 24 hours from randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1:1:1 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio
Hide Arm/Group Description:
1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Overall Number of Participants Analyzed 338 342
Median (Inter-Quartile Range)
Unit of Measure: units of blood products
16
(10 to 32)
15
(5 to 24)
7.Secondary Outcome
Title Functional Status at Time of Hospital Discharge
Hide Description The Glasgow Outcome Extended Score (GOSE) is a tool used to measure recovery following brain injury and assists with prediction of long-term rehabilitation. The 8 scoring categories are death, vegetative state, lower severe disability, upper severe disability, lower moderate disability, upper moderate disability, lower good recovery and upper good recovery. A higher GOSE score correlates with better outcome.
Time Frame Hospital discharge or 30 days, whichever comes first
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Glasgow Outcome Extended Score (GOSE) Score on discharged patients who had a head injury (Abbreviated Injury Score (AIS) > 1) ranging from 1 to 8. The AIS is a coding scale to classify the injury severity. A score is created for each body region, type of anatomic structure (i.e. whole area, vessels,organs), and severity(minor to maximum).
Arm/Group Title 1:1:1 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio
Hide Arm/Group Description:
1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Overall Number of Participants Analyzed 30 28
Median (Inter-Quartile Range)
Unit of Measure: units on the GOSE scale
4
(3 to 6)
4.5
(3.5 to 7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1:1 Blood Transfusion Ratio, 1:1:2 Blood Transfusion Ratio
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method van Elteren's test for medians
Comments [Not Specified]
8.Secondary Outcome
Title Incidence of Primary Surgical Procedure
Hide Description [Not Specified]
Time Frame ED admission to hospital discharge or 30 days, whichever comes first
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Incidence of primary surgical procedure
Arm/Group Title 1:1:1 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio
Hide Arm/Group Description:
1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Overall Number of Participants Analyzed 338 342
Measure Type: Number
Unit of Measure: participants
290 284
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1:1 Blood Transfusion Ratio, 1:1:2 Blood Transfusion Ratio
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 2.8
Confidence Interval (2-Sided) 95%
-2.8 to 8.3
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Incidence of Transfusion Related Serious Adverse Events
Hide Description [Not Specified]
Time Frame ED admission to hospital discharge or 30 days, whichever comes first
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Incidence of transfusion related serious adverse events-Reportable to FDA
Arm/Group Title 1:1:1 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio
Hide Arm/Group Description:
1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Overall Number of Participants Analyzed 338 342
Measure Type: Number
Unit of Measure: participants
1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1:1 Blood Transfusion Ratio, 1:1:2 Blood Transfusion Ratio
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.8 to 1.7
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Initial Hospital Discharge Status
Hide Description [Not Specified]
Time Frame Hospital discharge or 30 days, whichever comes first
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Disposition of subject at time of hospital discharge
Arm/Group Title 1:1:1 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio
Hide Arm/Group Description:
1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Overall Number of Participants Analyzed 338 342
Measure Type: Number
Unit of Measure: participants
Home 118 105
Remained hospitalized at 30 days 82 77
Other 59 71
Morgue 75 89
Unknown 4 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1:1 Blood Transfusion Ratio, 1:1:2 Blood Transfusion Ratio
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method generalized logit model regression
Comments [Not Specified]
11.Secondary Outcome
Title Ventilator Free Days
Hide Description [Not Specified]
Time Frame first 30 days after ED admission
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of ventilator free days for each group.
Arm/Group Title 1:1:1 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio
Hide Arm/Group Description:
1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Overall Number of Participants Analyzed 338 342
Median (Inter-Quartile Range)
Unit of Measure: days
8
(0 to 16)
7
(0 to 14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1:1 Blood Transfusion Ratio, 1:1:2 Blood Transfusion Ratio
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method van Elteren's test for medians
Comments [Not Specified]
12.Secondary Outcome
Title ICU Free Days
Hide Description [Not Specified]
Time Frame first 30 days after ED admission
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of ICU free days for each group.
Arm/Group Title 1:1:1 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio
Hide Arm/Group Description:
1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Overall Number of Participants Analyzed 338 342
Median (Inter-Quartile Range)
Unit of Measure: days
5
(0 to 11)
4
(0 to 10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1:1 Blood Transfusion Ratio, 1:1:2 Blood Transfusion Ratio
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method van Elteren's test for medians
Comments [Not Specified]
13.Secondary Outcome
Title Amount of Blood Products Given From Hemostasis to 24 Hours After ED Admission
Hide Description [Not Specified]
Time Frame 24 hours after ED admission
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Unit of measure for outcome measures below is median number of blood product units that given in each group (1:1:1 or 1:1:2) from time initial hemostasis was complete (PROPPR randomized study products stopped) up to 24 hours following ED admission. Number of participants is based on those who survived up to 24 hours, not participants randomized.
Arm/Group Title 1:1:1 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio
Hide Arm/Group Description:
1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Overall Number of Participants Analyzed 316 305
Median (Inter-Quartile Range)
Unit of Measure: units of blood products
1
(0 to 6)
2
(0 to 9)
Time Frame up to 30 days following ED admission
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1:1:1 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio
Hide Arm/Group Description 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol. 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
All-Cause Mortality
1:1:1 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1:1:1 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/338 (0.59%)      4/342 (1.17%)    
Cardiac disorders     
Transfusion-associated circulatory overload  [1]  1/338 (0.30%)  1 0/342 (0.00%)  0
Metabolism and nutrition disorders     
Hypernatremia associated with hypertonic saline use  [2]  1/338 (0.30%)  1 4/342 (1.17%)  4
Indicates events were collected by systematic assessment
[1]
Serious adverse event reportable to FDA
[2]
Serious adverse events reportable to FDA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1:1:1 Blood Transfusion Ratio 1:1:2 Blood Transfusion Ratio
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   297/338 (87.87%)      310/342 (90.64%)    
Cardiac disorders     
Cardiac arrest   23/338 (6.80%)  25 27/342 (7.89%)  30
Myocardial Infarction   0/338 (0.00%)  0 2/342 (0.58%)  2
General disorders     
Systemic inflammatory response syndrome   231/338 (68.34%)  265 216/342 (63.16%)  239
Abdominal Complication  [1]  24/338 (7.10%)  29 22/342 (6.43%)  23
Multiple Organ Failure   20/338 (5.92%)  24 15/342 (4.39%)  18
Additional bleeding after hemostasis requiring intervention  [2]  13/338 (3.85%)  13 16/342 (4.68%)  18
Abdominal Compartment syndrome   3/338 (0.89%)  3 3/342 (0.88%)  3
Transfusion-related allergic reaction   2/338 (0.59%)  2 1/342 (0.29%)  1
Immune system disorders     
Delayed serological transfusion reaction   2/338 (0.59%)  2 0/342 (0.00%)  0
Febrile nonhemolytic transfusion reaction   1/338 (0.30%)  1 1/342 (0.29%)  1
Infections and infestations     
Sepsis   99/338 (29.29%)  110 91/342 (26.61%)  102
Infection  [3]  98/338 (28.99%)  155 106/342 (30.99%)  146
Ventilator-associated pneumonia   62/338 (18.34%)  70 58/342 (16.96%)  65
Metabolism and nutrition disorders     
Transfusion-related metabolic complications  [4]  53/338 (15.68%)  53 59/342 (17.25%)  60
Nervous system disorders     
Stroke   8/338 (2.37%)  9 11/342 (3.22%)  11
Renal and urinary disorders     
Acute Kidney Injury   74/338 (21.89%)  87 85/342 (24.85%)  93
Respiratory, thoracic and mediastinal disorders     
Acute Lung Injury   47/338 (13.91%)  56 57/342 (16.67%)  66
Acute Respiratory Distress Syndrome   46/338 (13.61%)  55 48/342 (14.04%)  57
Symptomatic pulmonary embolism   14/338 (4.14%)  14 13/342 (3.80%)  13
Asymptomatic pulmonary embolism   11/338 (3.25%)  11 11/342 (3.22%)  11
Vascular disorders     
Deep Vein Thrombosis   25/338 (7.40%)  28 24/342 (7.02%)  24
Indicates events were collected by systematic assessment
[1]
Also includes complications related to injury
[2]
bleeding occurring after hemostasis requiring an interventional radiology or surgical procedure
[3]
Includes urinary tract infection, wound infection, line infection and other. Data is not available for the specific types of infection (i.e. urinary, wound, line).
[4]
Hypocalcemia and hyperkalemia only
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: John Holcomb, M.D.
Organization: University of Texas Health Science Center - Houston
Phone: 713-500-5493
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Holcomb, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01545232     History of Changes
Other Study ID Numbers: HSC-GEN-11-0174
U01HL077863 ( U.S. NIH Grant/Contract )
First Submitted: February 29, 2012
First Posted: March 6, 2012
Results First Submitted: April 22, 2015
Results First Posted: June 3, 2015
Last Update Posted: November 30, 2017