Actively Recruiting
Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
Led by University of Alabama at Birmingham · Updated on 2025-08-21
1100
Participants Needed
13
Research Sites
204 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare the effectiveness of unseparated whole blood (referred to as Low-Titer Group O Whole Blood) and the separate components of whole blood (including red cells, plasma, platelets, and cryoprecipitate) in critically injured patients who require large-volume blood transfusions.
CONDITIONS
Official Title
Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult trauma patient (estimated age > 15 or weight > 50 kg, if age unknown)
- Patient taken to trauma center directly from scene
- Commencement of blood transfusion (PRBC, plasma or LTOWB), in pre-hospital or in-hospital setting
- Activation of site-specific Massive Hemorrhage Protocol or Massive Transfusion Protocol
- Traumatic injury with at least one of the following:
- Confirmed or suspected acute major bleeding
- Assessment of Blood Consumption (ABC) Score 2
You will not qualify if you...
- Patients who have received more than two units of LTOWB or the equivalent in components before enrollment
- Patients transferred from another hospital
- Children under 15 years old
- Known prisoners or individuals involuntarily confined
- Moribund patients expected to die within 1 hour
- Patients who required an emergency thoracotomy or more than 5 minutes of CPR before randomization
- Patients with known do not resuscitate orders prior to randomization
- Patients who refuse blood product administration
- Individuals with a research opt-out bracelet
- Patients with greater than 20% total body surface area burns
- Suspected inhalation injury victims
- Patients who are obviously pregnant or known to be pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
University of Alabama at Birmingham, UAB Hospital
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Los Angeles County + University of Southern California (LAC + USC) Medical Center
Los Angeles, California, United States, 90033
Not Yet Recruiting
3
University Medical Center New Orleans LCMC Health
New Orleans, Louisiana, United States, 70112
Not Yet Recruiting
4
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Not Yet Recruiting
5
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Not Yet Recruiting
6
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Not Yet Recruiting
7
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
Actively Recruiting
8
Oregon Health and Sciences University Hospital
Portland, Oregon, United States, 97239
Not Yet Recruiting
9
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
10
University of Texas Health Science Center Houston
Houston, Texas, United States, 77030
Not Yet Recruiting
11
University of Texas Health San Antonio and University Health System
San Antonio, Texas, United States, 78229
Not Yet Recruiting
12
Harborview Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
13
Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
Research Team
S
Shannon Stephens, EMTP, CCEMTP
CONTACT
K
Kiran Mansoor, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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