Home › Thromboembolism › NCT07290634

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

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

Who can join

Ages 18 and older · All sexes

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

About the study

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).

What is being tested

• Number of Participants with massive blood transfusion (procedure)

Sponsor: Zeliha Alicikus · Participants: 4 · Started: Apr 30, 2026

Contact the study team

• Ayten SARAÇOĞLU, Prof,MD · Phone: +1 (904) 524-4331
• Tolga SARAÇOĞLU, Prof,MD · Phone: +1 (904) 524-5932

Official record on ClinicalTrials.gov — NCT07290634

Locations in the U.S.

Conditions

• Thromboembolism
• Thrombocytopenia

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.