Comparing whole blood and blood components for trauma resuscitation

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

This study tests whether using whole blood instead of separated blood components can help critically injured patients who are losing a lot of blood survive and recover better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1100 (estimated)
• Ages: 15 Years and up
• Sex: All
• Sponsor: University of Alabama at Birmingham (Academic / other)
• Locations: 13 sites (Birmingham, Alabama and 12 other locations)
• Trial ID: NCT05638581 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of Low-Titer Group O Whole Blood (LTOWB) versus separated blood components in critically injured patients requiring large-volume blood transfusions. The study will randomize adult trauma patients with hemorrhagic shock to receive either LTOWB or standard blood components, allowing for a direct comparison of clinical outcomes. Given the high incidence of preventable deaths due to hemorrhage in trauma cases, this trial seeks to determine if whole blood transfusions can improve survival and recovery rates compared to traditional component therapy. The findings could lead to a significant shift in trauma transfusion practices.

Who should consider this trial

Good fit: Ideal candidates include adult trauma patients with confirmed or suspected major bleeding who are expected to require massive blood transfusions.

Not a fit: Patients who have already received more than two units of LTOWB or equivalent blood components prior to enrollment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve survival rates and recovery outcomes for trauma patients experiencing massive hemorrhage.

How similar studies have performed: While there have been a few observational studies on whole blood versus component therapy, this trial represents a more rigorous and direct comparison, making it a novel approach.

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 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

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 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

Where this trial is running

Birmingham, Alabama and 12 other locations

• University of Alabama at Birmingham, UAB Hospital — Birmingham, Alabama, United States (Recruiting)
• Los Angeles County + University of Southern California (LAC + USC) Medical Center — Los Angeles, California, United States (Not_yet_recruiting)
• University Medical Center New Orleans LCMC Health — New Orleans, Louisiana, United States (Not_yet_recruiting)
• University of Maryland Medical Center — Baltimore, Maryland, United States (Not_yet_recruiting)
• Washington University School of Medicine — St Louis, Missouri, United States (Not_yet_recruiting)
• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (Not_yet_recruiting)
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States (Recruiting)
• Oregon Health and Sciences University Hospital — Portland, Oregon, United States (Not_yet_recruiting)
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
• University of Texas Health Science Center Houston — Houston, Texas, United States (Not_yet_recruiting)
• University of Texas Health San Antonio and University Health System — San Antonio, Texas, United States (Not_yet_recruiting)
• Harborview Medical Center — Seattle, Washington, United States (Recruiting)
• Froedtert Hospital — Milwaukee, Wisconsin, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Jan Jansen, MBBS, PhD — University of Alabama at Birmingham
• Study coordinator: Shannon Stephens, EMTP, CCEMTP

Conditions Wounds and Injuries; Shock, Hemorrhagic; Massive Transfusion; Trauma; Shock; Hemorrhage; Plasma; Platelets