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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT05638581
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Shock, Hemorrhagic
  • Wounds and Injuries

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LTOWB — BIOLOGICAL
    Participants will receive Low Titer O Whole Blood administered intravenously or intraosseously.
  • Components — BIOLOGICAL
    Participants will receive separated blood components (i.e., units of red cells, plasma, platelets, and cryoprecipitate) co-administered intravenously or intraosseously.

Study Details

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 Dates

Start date
Jul 27, 2023
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
1,100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham, UAB HospitalBirminghamAlabama35294
Jonah Celeski
[email protected]
Emily Turner
[email protected]
Richard Betzold, MD (PRINCIPAL_INVESTIGATOR)
Los Angeles County + University of Southern California (LAC + USC) Medical CenterLos AngelesCalifornia90033-
University Medical Center New Orleans LCMC HealthNew OrleansLouisiana70112-
University of Maryland Medical CenterBaltimoreMaryland21201-
Washington University School of MedicineSt LouisMissouri63110-
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157-
University of Cincinnati Medical CenterCincinnatiOhio45267
Robbie Jones
[email protected]
Devin Wakefield
[email protected]
Michael Goodman, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Sciences University HospitalPortlandOregon97239-
Penn Presbyterian Medical CenterPhiladelphiaPennsylvania19104-
University of Texas Health Science Center HoustonHoustonTexas77030-
University of Texas Health San Antonio and University Health SystemSan AntonioTexas78229-
Harborview Medical CenterSeattleWashington98104
Laura Hennessy
[email protected]
Allison Larimore
[email protected]
Bryce Robinson, MD (PRINCIPAL_INVESTIGATOR)
Froedtert HospitalMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham, UAB Hospital· Birmingham, ALLos Angeles County + University of Southern California (LAC + USC) Medical Center· Los Angeles, CAUniversity Medical Center New Orleans LCMC Health· New Orleans, LAUniversity of Maryland Medical Center· Baltimore, MDWashington University School of Medicine· St Louis, MOAtrium Health Wake Forest Baptist· Winston-Salem, NC

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