Comparative Outcomes of Prothrombin Complex Concentrate and Recombinant Activated Factor VIIa in Trauma-Associated Massive Transfusion: A Retrospective Cohort Study
Zeliha Alicikus
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).
Description
Trauma-induced coagulopathy (TIC) is a multifactorial disorder that occurs in nearly one-third of severely injured patients and is closely linked to increased transfusion requirements, multiorgan failure, and higher mortality rates. Despite progress in trauma care and surgical interventions, hemorrhage and TIC remain leading contributors to preventable trauma-related deaths. Conventional resuscitation approaches primarily involve fresh frozen plasma (FFP) and platelet transfusions; however, these blood products are constrained by delayed availability, large infusion volumes, and inconsistent…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults ≥18 years * Trauma patients directly admitted from the scene with highest-level trauma activation: Injury -Severity Score (ISS) \>15. * Requirement for massive transfusion, defined as ≥3 units packed red blood cells (PRBC) within the first hour or ≥10 PRBC within the first 24 hours Exclusion Criteria: * Traumatic cardiac injury * Death anticipated within the first hour of admission: ISS score \>49 * Pre-injury anticoagulant therapy * Known pregnancy * Pre-injury terminal illness
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
- UF Health Jacksonville (Shands Hospital)Jacksonville, Florida