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

Inclusion Criteria7

  • 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

Exclusion Criteria12

  • 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

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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

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NCT05638581


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