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

Last updated: February 27, 2025
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Components

LTOWB

Clinical Study ID

NCT05638581
1UG3HL157401-01A1
1UG3HL157401-01A1
1U24HL157310-01A1
  • Ages > 15
  • All Genders

Study 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

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 orin-hospital setting

  4. Activation of site-specific Massive Hemorrhage Protocol or Massive TransfusionProtocol

  5. Traumatic injury with at least one of the following:

  6. Confirmed or suspected acute major bleeding

  7. Assessment of Blood Consumption (ABC) Score ≥2

Exclusion

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 ofplasma); or a combination of the two (more than one unit of LTOWB, one unit ofpacked cells, and one unit of plasma). Most trauma centers hold two units of eitherpacked red blood cells (with two units of plasma) or two units of LTOWB in theemergency department. This stock is used to initiate transfusion, while the massivehemorrhage 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 atadult trauma centers, and patients in this age group frequently sufferlife-threatening injuries, and will therefore be included)

  4. Known prisoners, defined as individuals involuntarily confined or detained in apenal 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 minutesof 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 pregnantas provided by the subject or legally authorized representative

Study Design

Total Participants: 1100
Treatment Group(s): 2
Primary Treatment: Components
Phase: 3
Study Start date:
July 27, 2023
Estimated Completion Date:
June 30, 2027

Study Description

Trauma is one of the leading causes of death in the United States, and disproportionately affects the young, killing those who might otherwise have lived long and productive lives. Injuries account for more years of potential life lost before age 75 than any other cause. Hemorrhage remains the most common cause of preventable death after injury, and blood transfusion is an essential part of treatment. Modern blood banking practices separate donated whole blood into components. The current standard of care in trauma transfusion is the balanced administration of equal numbers of units of blood components (packed red blood cells, plasma, and platelets), effectively attempting to reconstitute whole blood. A renewed approach to blood transfusion therapy in trauma is to use whole blood from the outset, which has not been separated. Compared with component therapy, whole blood offers several potential advantages, but there are only a small number of, mostly observational, studies comparing whole blood and component therapy, and they are very heterogeneous.

The TROOP trial will include injured adults with hemorrhagic shock anticipated to require massive blood transfusions, who will be randomized to receive either whole blood (LTOWB) or blood components. This will allow a direct comparison to see if one type of transfusion is more strongly associated with improved clinical outcomes over the other.

The knowledge gained from this clinical trial will transform the way in which massively bleeding trauma patients are transfused. The trial is exceedingly well positioned to improve mortality from trauma and reduce the number of preventable deaths resulting from hemorrhagic shock.

Connect with a study center

  • University of Alabama at Birmingham, UAB Hospital

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Los Angeles County + University of Southern California (LAC + USC) Medical Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • University Medical Center New Orleans LCMC Health

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • University of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

  • Oregon Health and Sciences University Hospital

    Portland, Oregon 97239
    United States

    Site Not Available

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Texas Health Science Center Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas Health San Antonio and University Health System

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Harborview Medical Center

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • Froedtert Hospital

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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