Trauma Resuscitation With Low-Titer Group O Whole Blood or Products

Recruiting now · Phase 3

Conditions studied: Wounds and Injuries, Shock, Hemorrhagic

In brief

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.

Key facts

Study ID

NCT05638581

Run by

University of Alabama at Birmingham

People needed

1100

Starts

2023-07-27

Expected to finish

2027-06-30

Last updated by the study team

2025-08-21

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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.
• Patients transferred from another hospital
• 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)
• 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)
• Moribund patients expected to die within 1 hour
• Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products)
• Patients with known "do not resuscitate" orders prior to randomization
• Patients who refuse the administration of blood products
• Individuals with a research "opt out" bracelet.
• Greater than 20% total body surface area (TBSA) burns
• Suspected inhalation injury victims
• Patients who are obviously pregnant on clinical examination or known to be pregnant as provided by the subject or legally authorized representative

Where it is running

• University of Alabama at Birmingham, UAB Hospital — Birmingham, Alabama, United States (enrolling)
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States (enrolling)
• Harborview Medical Center — Seattle, Washington, United States (enrolling)
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States
• Froedtert Hospital — Milwaukee, Wisconsin, United States
• Oregon Health and Sciences University Hospital — Portland, Oregon, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• University of Texas Health Science Center Houston — Houston, Texas, United States
• University of Texas Health San Antonio and University Health System — San Antonio, Texas, United States
• Los Angeles County + University of Southern California (LAC + USC) Medical Center — Los Angeles, California, United States
• University Medical Center New Orleans LCMC Health — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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