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RecruitingPhase 3NCT05638581

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

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Trial Parameters

ConditionWounds and Injuries
SponsorUniversity of Alabama at Birmingham
Study TypeINTERVENTIONAL
PhasePhase 3
Enrollment1,100
SexALL
Min Age15 Years
Max AgeN/A
Start Date2023-07-27
Completion2026-12-31
Interventions
LTOWBComponents

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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.

Eligibility Criteria

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, w

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