Actively Recruiting
Comparative Outcomes of PCC and Recombinant Activated Factor VIIa in Trauma-Associated Massive Transfusion
Led by Zeliha Alicikus · Updated on 2026-04-14
4
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comparative Outcomes of PCC and Recombinant Activated Factor VIIa in Trauma-Associated Massive Transfusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 65 18 years
- Trauma patients admitted directly from the scene with highest-level trauma activation
- Injury Severity Score (ISS) > 15
- Requirement for massive transfusion defined as 65 3 units packed red blood cells within the first hour or 65 10 units within the first 24 hours
You will not qualify if you...
- Traumatic cardiac injury
- Death anticipated within the first hour of admission: ISS score > 49
- Pre-injury anticoagulant therapy
- Known pregnancy
- Pre-injury terminal illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
UF Health Jacksonville (Shands Hospital)
Jacksonville, Florida, United States, 32209
Actively Recruiting
2
UF Health Jacksonville (Shands Hospital)
Jacksonville, Florida, United States, 32218
Actively Recruiting
Research Team
A
Ayten SARAÇOĞLU, Prof,MD
CONTACT
T
Tolga SARAÇOĞLU, Prof,MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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