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Completed
NCT07290634
Comparative Outcomes of PCC and Recombinant Activated Factor VIIa in Trauma-Associated Massive Transfusion
Conditions: Thromboembolus, Massive Blood Transfusion; Thrombocytopenia, Trauma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 75
Sponsor: Zeliha Alicikus
Location: UF Health Jacksonville (Shands Hospital) Jacksonville Florida
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 Criteria
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
Source: ClinicalTrials.gov (NCT07290634). StuddyBuddy aggregates publicly available trial information.