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

Description

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.

Conditions

Wounds and Injuries, Shock, Hemorrhagic

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Wounds and Injuries
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, UAB Hospital, Birmingham, Alabama, United States, 35294

Los Angeles

Los Angeles County + University of Southern California (LAC + USC) Medical Center, Los Angeles, California, United States, 90033

New Orleans

University Medical Center New Orleans LCMC Health, New Orleans, Louisiana, United States, 70112

Baltimore

University of Maryland Medical Center, Baltimore, Maryland, United States, 21201

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Winston-Salem

Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina, United States, 27157

Cincinnati

University of Cincinnati Medical Center, Cincinnati, Ohio, United States, 45267

Portland

Oregon Health and Sciences University Hospital, Portland, Oregon, United States, 97239

Philadelphia

Penn Presbyterian Medical Center, Philadelphia, Pennsylvania, United States, 19104

Houston

University of Texas Health Science Center Houston, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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, while the massive hemorrhage protocol is activated from the blood bank.
  • 2. Patients transferred from another hospital
  • 3. 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)
  • 4. 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)
  • 5. Moribund patients expected to die within 1 hour
  • 6. Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products)
  • 7. Patients with known "do not resuscitate" orders prior to randomization
  • 8. Patients who refuse the administration of blood products
  • 9. Individuals with a research "opt out" bracelet.
  • 10. Greater than 20% total body surface area (TBSA) burns
  • 11. Suspected inhalation injury victims
  • 12. Patients who are obviously pregnant on clinical examination or known to be pregnant as provided by the subject or legally authorized representative

Ages Eligible for Study

15 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Alabama at Birmingham,

Jan Jansen, MBBS, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

2027-06-30