RecruitingPhase 3NCT05638581

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


Sponsor

University of Alabama at Birmingham

Enrollment

1,100 participants

Start Date

Jul 27, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This large randomized trial compares two approaches to blood transfusion for trauma patients who are bleeding severely: transfusing whole blood (low-titer group O whole blood, LTOWB) versus the standard approach of giving separate components (packed red blood cells and plasma). The goal is to find out which method leads to better survival and outcomes after major traumatic injury. You may be eligible if... - You are an adult trauma patient (or over 15 years old, or over 50 kg) - You were brought directly to a trauma center from the scene of injury - You required blood transfusion and triggered the massive hemorrhage/transfusion protocol - You have confirmed or suspected major bleeding from trauma You may NOT be eligible if... - You were transferred from another hospital - You are under 15 years old - You have severe burns (over 20% body surface area) - You are obviously pregnant - You have a "do not resuscitate" order - You are expected to die within 1 hour - You refuse blood products - You have already received more than 2 units of whole blood or the equivalent in components before enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALLTOWB

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

BIOLOGICALComponents

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


Locations(13)

University of Alabama at Birmingham, UAB Hospital

Birmingham, Alabama, 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

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

University of Cincinnati Medical Center

Cincinnati, Ohio, 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

Harborview Medical Center

Seattle, Washington, United States

Froedtert Hospital

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05638581


Related Trials