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

NCT07290634 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 4

Last updated 2026-04-14

No results posted yet for this study

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).

Conditions

  • Thromboembolus
  • Massive Blood Transfusion; Thrombocytopenia
  • Trauma

Interventions

PROCEDURE

Number of Participants with massive blood transfusion

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

Sponsors & Collaborators

  • Zeliha Alicikus

    lead OTHER_GOV

Principal Investigators

  • AYTEN SARAÇOĞLU, Prof,MD · Florida University Jacksonville

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-05-30
Completion
2026-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07290634 on ClinicalTrials.gov