Comparative Outcomes of PCC and Recombinant Activated Factor VIIa in Trauma-Associated Massive Transfusion
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
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 design
Treatments tested in this trial
- Number of Participants with massive blood transfusion
Treatment groups
4 Participants
are divided into 4 treatment groupsSponsors and collaborators
Zeliha Alicikus
Lead sponsor
Umraniye Education and Research Hospital
Sponsor institution
Source ClinicalTrials.gov