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

StatusCompleted
PhaseNot specified
Started

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Record History

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  1. Trial completed
    • Final enrollment: 75 participants (planned 4)
    • Eligibility criteria expanded, about 8 words
    • Site details revised at 2 of 2 sites
  2. Start date: Jan 30, 2026 to Apr 30, 2026v3
  3. Interventions: massive blood transfusion (Procedure) to Number of Participants with massive blood transfusion (Procedure)v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07290634
Lead Sponsor Zeliha Alicikus
Conditions
(from sponsor)		 Thromboembolus, Massive Blood Transfusion; Thrombocytopenia, Trauma
Related terms Thrombocytopenia, Thromboembolism, Wounds and Injuries
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov