Clinical Trial

Comparative Outcomes of PCC and Recombinant Activated Factor VIIa in Trauma-Associated Massive Transfusion

Recruiting
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Record status
This record was last updated April 14, 2026 (before its estimated May 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
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).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-12-16; most recent amendment 2026-04-11.
Trial Details
NCT Number NCT07290634
Lead Sponsor Zeliha Alicikus
Conditions Thromboembolus, Massive Blood Transfusion; Thrombocytopenia, Trauma
Enrollment 4 participants
Start Date 2026-04-30
Primary Completion 2026-05-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-14