Actively Recruiting

Phase 3
Age: 15Years +
All Genders
NCT05638581

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

Age: 15Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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