RecruitingNot Applicable

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

United States4 participantsStarted 2026-04-30

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

thromboembolic events

Timeframe: 28 days

Trial details

NCT IDNCT07290634

SponsorZeliha Alicikus

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2026-05-30

Contact for this trial

Ayten SARAÇOĞLU, Prof,MD

+1 (904) 524-4331 anesthesiayten@gmail.com

View on ClinicalTrials.gov More Thromboembolus trials