Comparative Outcomes of PCC and Recombinant Activated Factor VIIa in Trauma-Associated Massive Transfusion
Recruiting now
Conditions studied: Thromboembolus, Massive Blood Transfusion; Thrombocytopenia, Trauma
In brief
This study aims to compare the incidence of thromboembolic complications among trauma patients receiving PCC, rFVIIa, both agents, or neither during massive transfusion. Secondary objectives include comparing mortality, transfusion requirements, intensive care unit (ICU) and hospital length of stay, ventilator-free days, and the incidence of transfusion-associated adverse events such as transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO). Subgroup analyses will evaluate outcomes in patients with and without laboratory-confirmed TIC (INR \>1.2).
Key facts
- Study ID
- NCT07290634
- Run by
- Zeliha Alicikus
- People needed
- 4
- Starts
- 2026-04-30
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2026-04-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults ≥18 years
- Trauma patients directly admitted from the scene with highest-level trauma activation: Injury -Severity Score (ISS) >15.
- Requirement for massive transfusion, defined as ≥3 units packed red blood cells (PRBC) within the first hour or ≥10 PRBC within the first 24 hours
You may not qualify if…
- Traumatic cardiac injury
- Death anticipated within the first hour of admission: ISS score >49
- Pre-injury anticoagulant therapy
- Known pregnancy
- Pre-injury terminal illness
Where it is running
- UF Health Jacksonville (Shands Hospital) — Jacksonville, Florida, United States (enrolling)
- UF Health Jacksonville (Shands Hospital) — Jacksonville, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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