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

ConditionsThromboembolusMassive Blood Transfusion; ThrombocytopeniaTrauma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZeliha Alicikus

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Traumatic cardiac injury

Death anticipated within the first hour of admission: ISS score >49

Pre-injury anticoagulant therapy

Known pregnancy

Trial population

This will be a retrospective cohort study conducted between 1 January 2023 to 1 October 2025 at University of Florida Jacksonville trauma center. The study will evaluate the impact of Prothrombin Complex, recombinant activated factor VII, and their combination on outcomes in adult trauma patients undergoing massive transfusion.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Number of Participants with massive blood transfusion

    Procedure/Surgery

    evaluate the impact of Prothrombin Complex, recombinant activated factor VII, and their combination on outcomes in adult trauma patients undergoing massive transfusion.

Treatment groups

4 Participants
are divided into 4 treatment groups
Group A: PCC group1 intervention
Group B: rFVIIa group1 intervention
Group C: Combination group1 intervention
Group D: Control group1 intervention

Trial outcomes

Primary outcomes

1

thromboembolic events

Number of Participants with venous thrombosis, pulmonary embolism, ischemic stroke, mesenteric ischemia

Time frame
28 days

Secondary outcomes

1

ICU and hospital stay

length of stay day

Time frame
28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zeliha Alicikus

Lead sponsor

Umraniye Education and Research Hospital

Sponsor institution

Source ClinicalTrials.gov
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