NCT05638581 Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
| NCT ID | NCT05638581 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Alabama at Birmingham |
| Condition | Wounds and Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2023-07-27 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,100 participants in total. It began in 2023-07-27 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Jan Jansen, MBBS, PhD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT05638581 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying Wounds and Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05638581 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,100 participants.
Is NCT05638581 currently recruiting?
Yes, NCT05638581 is actively recruiting participants. Contact the research team at swstephens@uabmc.edu for enrollment information.
Where is the NCT05638581 trial being conducted?
This trial is being conducted at Birmingham, United States, Los Angeles, United States, New Orleans, United States, Baltimore, United States and 9 additional locations.
Who is sponsoring the NCT05638581 clinical trial?
NCT05638581 is sponsored by University of Alabama at Birmingham. The principal investigator is Jan Jansen, MBBS, PhD at University of Alabama at Birmingham. The trial plans to enroll 1,100 participants.