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Early Whole Blood in Patients Requiring Transfusion After Major Trauma

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ClinicalTrials.gov Identifier: NCT01227005
Recruitment Status : Completed
First Posted : October 22, 2010
Results First Posted : May 28, 2015
Last Update Posted : June 4, 2018
Sponsor:
Collaborator:
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
Bryan Cotton, 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/Injury Problem
Intervention Biological: Transfusion of blood products
Enrollment 107
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Whole Blood Component Therapy
Hide Arm/Group Description

Whole Blood plus pooled platelets

Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).

Red blood cells, plasma, platelets

Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).

Period Title: Overall Study
Started 55 52
Completed 50 51
Not Completed 5 1
Arm/Group Title Whole Blood Component Therapy Total
Hide Arm/Group Description

Whole Blood plus pooled platelets

Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).

Red blood cells, plasma, platelets

Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).

Total of all reporting groups
Overall Number of Baseline Participants 55 52 107
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 55 participants 52 participants 107 participants
40
(29 to 56)
38
(32 to 56)
39
(30 to 56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 52 participants 107 participants
Female
12
  21.8%
9
  17.3%
21
  19.6%
Male
43
  78.2%
43
  82.7%
86
  80.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants 52 participants 107 participants
55 52 107
1.Primary Outcome
Title Units of Blood Products Required During the First 24 Hours After Emergency Department Admission
Hide Description Compare the ability of whole blood to reduce initial 24-hour transfusion requirements as compared to component therapy (red blood cells, plasma, and platelet units)
Time Frame first 24 hours after ED admission
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whole Blood Component Therapy
Hide Arm/Group Description:

Whole Blood plus pooled platelets

Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).

Red blood cells, plasma, platelets

Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).

Overall Number of Participants Analyzed 55 52
Median (Inter-Quartile Range)
Unit of Measure: units of blood
12
(6 to 24)
13
(5 to 29)
2.Secondary Outcome
Title 24-hour Mortality
Hide Description Mortality rate at 24 hours after arrival
Time Frame First 24 hours after ED admission
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whole Blood Component Therapy
Hide Arm/Group Description:

Whole Blood plus pooled platelets

Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).

Red blood cells, plasma, platelets

Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).

Overall Number of Participants Analyzed 55 52
Measure Type: Number
Unit of Measure: participants
12 7
3.Secondary Outcome
Title 30-day Mortality
Hide Description Evaluate 30-day mortality among those receiving whole blood compared to those receiving component therapy
Time Frame first 30 days after ED admission
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whole Blood Component Therapy
Hide Arm/Group Description:

Whole Blood plus pooled platelets

Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).

Red blood cells, plasma, platelets

Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).

Overall Number of Participants Analyzed 55 52
Measure Type: Number
Unit of Measure: participants
15 8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Whole Blood Component Therapy
Hide Arm/Group Description

Whole Blood plus pooled platelets

Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).

Red blood cells, plasma, platelets

Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).

All-Cause Mortality
Whole Blood Component Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Whole Blood Component Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/55 (0.00%)      0/52 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Whole Blood Component Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/55 (1.82%)      0/52 (0.00%)    
Blood and lymphatic system disorders     
Allergic reaction to blood product  [1]  1/55 (1.82%)  1 0/52 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Allergic reaction to blood product in WB arm.
First, we failed to specifically exclude patients with severe TBI from our initial protocol. Finally, we did not use an objective scoring system to randomize patients and, therefore, did not always include patients who would have received an MT.
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
Layout table for Results Point of Contact information
Name/Title: Bryan A. Cotton, MD, MPH
Organization: University of Texas Health Science Center-Houston
Phone: 713-500-7354
EMail: bryan.a.cotton@uth.tmc.edu
Layout table for additonal information
Responsible Party: Bryan Cotton, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01227005    
Other Study ID Numbers: W81XWH-07-1-0229
First Submitted: October 20, 2010
First Posted: October 22, 2010
Results First Submitted: May 19, 2014
Results First Posted: May 28, 2015
Last Update Posted: June 4, 2018