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RECRUITING
NCT07290634

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

Sponsor: Zeliha Alicikus

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

4

Start Date

2026-01-30

Completion Date

2026-06-30

Last Updated

2025-12-23

Healthy Volunteers

No

Interventions

PROCEDURE

Number 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