Comparing Prothrombin Complex Concentrate and Recombinant Activated Factor VIIa in Adults with Severe Trauma Requiring Massive Blood Transfusion

What this Trial Is About

Researchers are evaluating the effects of prothrombin complex concentrate PCC, recombinant activated factor VIIa rFVIIa, both agents combined, or neither on trauma patients undergoing massive blood transfusion. The study aims to compare rates of blood clot complications and also examines secondary outcomes such as death rates, transfusion needs, lengths of stay in intensive care and hospitals, ventilator-free days, and risks of transfusion-related lung injury or circulatory overload. Subgroup analyses will explore differences between patients with and without trauma-induced coagulopathy confirmed by lab tests. The study groups include trauma patients receiving PCC during resuscitation, those receiving rFVIIa, patients treated with both PCC and rFVIIa, and a control group receiving standard resuscitation without these agents. Researchers will collect data retrospectively to assess how these treatments influence outcomes during massive transfusion. Participants are adult trauma patients admitted directly from the scene with severe injuries and who require massive transfusion defined by specific blood product volume thresholds. Data collection includes monitoring thromboembolic events over 28 days and tracking intensive care and hospital stays for the same period. The study will provide insights into treatment impacts, safety, and complications after trauma-associated massive transfusion.

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