Trial Outcomes & Findings for Early Whole Blood in Patients Requiring Transfusion After Major Trauma (NCT NCT01227005)
NCT ID: NCT01227005
Last Updated: 2018-06-04
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
107 participants
Primary outcome timeframe
first 24 hours after ED admission
Results posted on
2018-06-04
Participant Flow
Participant milestones
| Measure |
Whole Blood
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).
|
Component Therapy
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 Study
STARTED
|
55
|
52
|
|
Overall Study
COMPLETED
|
50
|
51
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Whole Blood in Patients Requiring Transfusion After Major Trauma
Baseline characteristics by cohort
| Measure |
Whole Blood
n=55 Participants
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).
|
Component Therapy
n=52 Participants
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
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
n=5 Participants
|
38 years
n=7 Participants
|
39 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
52 participants
n=7 Participants
|
107 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: first 24 hours after ED admissionCompare the ability of whole blood to reduce initial 24-hour transfusion requirements as compared to component therapy (red blood cells, plasma, and platelet units)
Outcome measures
| Measure |
Whole Blood
n=55 Participants
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).
|
Component Therapy
n=52 Participants
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).
|
|---|---|---|
|
Units of Blood Products Required During the First 24 Hours After Emergency Department Admission
|
12 units of blood
Interval 6.0 to 24.0
|
13 units of blood
Interval 5.0 to 29.0
|
SECONDARY outcome
Timeframe: First 24 hours after ED admissionMortality rate at 24 hours after arrival
Outcome measures
| Measure |
Whole Blood
n=55 Participants
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).
|
Component Therapy
n=52 Participants
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).
|
|---|---|---|
|
24-hour Mortality
|
12 participants
|
7 participants
|
SECONDARY outcome
Timeframe: first 30 days after ED admissionEvaluate 30-day mortality among those receiving whole blood compared to those receiving component therapy
Outcome measures
| Measure |
Whole Blood
n=55 Participants
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).
|
Component Therapy
n=52 Participants
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).
|
|---|---|---|
|
30-day Mortality
|
15 participants
|
8 participants
|
Adverse Events
Whole Blood
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Component Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Whole Blood
n=55 participants at risk
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).
|
Component Therapy
n=52 participants at risk
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).
|
|---|---|---|
|
Blood and lymphatic system disorders
Allergic reaction to blood product
|
1.8%
1/55 • Number of events 1
|
0.00%
0/52
|
Additional Information
Bryan A. Cotton, MD, MPH
University of Texas Health Science Center-Houston
Phone: 713-500-7354
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place