RecruitingNCT07290634

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

Comparative Outcomes of Prothrombin Complex Concentrate and Recombinant Activated Factor VIIa in Trauma-Associated Massive Transfusion: A Retrospective Cohort Study


Sponsor

Zeliha Alicikus

Enrollment

4 participants

Start Date

Apr 30, 2026

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Number of Participants with massive blood transfusion for people with massive blood transfusion; thrombocytopenia, thromboembolus, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENumber of Participants with massive blood transfusion

evaluate the impact of Prothrombin Complex, recombinant activated factor VII, and their combination on outcomes in adult trauma patients undergoing massive transfusion.


Locations(2)

UF Health Jacksonville (Shands Hospital)

Jacksonville, Florida, United States

UF Health Jacksonville (Shands Hospital)

Jacksonville, Florida, United States

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NCT07290634


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