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

Recruiting Phase 3 Interventional Study
Wounds and Injuries Shock, Hemorrhagic
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
15 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,100 (estimated)
Sponsor
University of Alabama at Birmingham · Other
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About This Trial

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.

Trial Locations
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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 Hemo…
Contacts

Shannon Stephens, EMTP, CCEMTP

205-934-5890

swstephens@uabmc.edu

CONTACT

Kiran Mansoor, MBBS

713-500-9643

Kiran.Mansoor@uth.tmc.edu

CONTACT