Recruiting
Phase 3

Low-Titer O Whole Blood

Sponsor:

University of Alabama at Birmingham

Code:

NCT05638581

Conditions

Wounds and Injuries

Shock, Hemorrhagic

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Interventions

LTOWB

Components

Study Details

Brief summary:

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

Wounds and Injuries

Shock, Hemorrhagic

Study ID

NCT05638581

Start date

Jul 27, 2023

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adult trauma patient (estimated age > 15 or weight > 50 kg, if age unknown)
2. Patient taken to trauma center directly from scene
3. Commencement of blood transfusion (PRBC, plasma or LTOWB), in pre-hospital or in-hospital setting
4. Activation of site-specific Massive Hemorrhage Protocol or Massive Transfusion Protocol
5. Traumatic injury with at least one of the following:

1. Confirmed or suspected acute major bleeding
2. Assessment of Blood Consumption (ABC) Score ≥2

Exclusion Criteria:

1. Patients who have received, prehospital or in-hospital more than two units of LTOWB; the equivalent in components (two units of packed red blood cells and two units of plasma); or a combination of the two (more than one unit of LTOWB, one unit of packed cells, and one unit of plasma). Most trauma centers hold two units of either packed red blood cells (with two units of plasma) or two units of LTOWB in the emergency department. This stock is used to initiate transfusion, while the massive hemorrhage protocol is activated from the blood bank.
2. Patients transferred from another hospital
3. Children <15 years (in most communities, patients aged 15-18 years are treated at adult trauma centers, and patients in this age group frequently suffer life-threatening injuries, and will therefore be included)
4. Known prisoners, defined as individuals involuntarily confined or detained in a penal institution (including juvenile detention, involuntary psychiatric commitment, or court-ordered residential substance abuse treatment)
5. Moribund patients expected to die within 1 hour
6. Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products)
7. Patients with known "do not resuscitate" orders prior to randomization
8. Patients who refuse the administration of blood products
9. Individuals with a research "opt out" bracelet.
10. Greater than 20% total body surface area (TBSA) burns
11. Suspected inhalation injury victims
12. Patients who are obviously pregnant on clinical examination or known to be pregnant as provided by the subject or legally authorized representative

Study Design

Enrollment

1100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: LTOWB

Participants randomized to receive (Low Titer O Whole Blood \[LTOWB\])

active comparator: Components

Participants randomized to receive the component blood products.

Interventions

LTOWB

Participants will receive Low Titer O Whole Blood administered intravenously or intraosseously.

Components

Participants will receive separated blood components (i.e., units of red cells, plasma, platelets, and cryoprecipitate) co-administered intravenously or intraosseously.

Primary outcome measure

  • 6-hour Mortality [ Time Frame: First 6 hours after randomization ]

Central Contacts and Locations

Central contacts

Shannon Stephens, EMTP, CCEMTP

205-934-5890swstephens@uabmc.edu

Locations

University of Alabama at Birmingham, UAB Hospital

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Principal Investigator:

Richard Betzold, MD

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Principal Investigator:

Michael Goodman, MD

Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Laura Hennessy

hennessy@uw.edu

Allison Larimore

alari@uw.edu

Principal Investigator:

Bryce Robinson, MD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • Massive Transfusion
  • Trauma
  • Shock
  • Hemorrhage
  • Plasma
  • Platelets
  • Red Blood Cells
  • Low-Titer Group O Whole Blood
  • Blood components

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-08-11.