PCC versus recombinant activated factor VIIa for adults needing massive transfusion after trauma

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

This study will test whether giving PCC, rFVIIa, both, or neither during massive transfusion changes clotting complications and other outcomes in adult trauma patients.

Quick facts

• Study type: Observational
• Enrollment: 4 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Umraniye Education and Research Hospital (Government)
• Locations: 2 sites (Jacksonville, Florida and 1 other locations)
• Trial ID: NCT07290634 on ClinicalTrials.gov

What this trial studies

This is an observational comparison of adult trauma patients requiring massive transfusion at UF Health Jacksonville, grouping patients who received four-factor PCC, recombinant activated factor VIIa (rFVIIa), both agents, or neither. The primary focus is the incidence of thromboembolic complications, with secondary endpoints including mortality, transfusion volumes, ICU and hospital length of stay, ventilator-free days, and transfusion-associated events like TRALI and TACO. Subgroup analyses will compare outcomes for patients with laboratory-confirmed trauma-induced coagulopathy (INR > 1.2) versus those without. Eligible patients are adults with high-severity injuries (ISS > 15) who meet predefined massive transfusion thresholds.

Who should consider this trial

Good fit: Adults (≥18) with severe trauma (ISS > 15) brought directly from the scene under highest-level activation who require massive transfusion (≥3 PRBC in the first hour or ≥10 PRBC in 24 hours) and who are not pregnant, not on pre-injury anticoagulants, and without traumatic cardiac injury or pre-injury terminal illness.

Not a fit: Patients on pre-injury anticoagulants, with traumatic cardiac injury, expected to die within the first hour, who are pregnant, who have a pre-injury terminal illness, or who do not require massive transfusion would not be expected to benefit or qualify for this comparison.

Why it matters

Potential benefit: If successful, the findings could help clinicians choose transfusion adjuncts that reduce clotting complications and improve survival and resource use during massive transfusion.

How similar studies have performed: Previous randomized and observational studies of PCC and rFVIIa in trauma and trauma-induced coagulopathy have shown mixed results—some, like the PROCOAG trial, found no reduction in blood use and a higher rate of thromboembolic events—so the approach remains incompletely proven.

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

Where this trial is running

Jacksonville, Florida and 1 other locations

• UF Health Jacksonville (Shands Hospital) — Jacksonville, Florida, United States (Recruiting)
• UF Health Jacksonville (Shands Hospital) — Jacksonville, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Ayten SARAÇOĞLU, Prof,MD

Conditions Thromboembolus; Massive Blood Transfusion; Thrombocytopenia; Trauma