Actively Recruiting
Comparative Outcomes of Prothrombin Complex Concentrate and Recombinant Activated Factor VIIa in Trauma-Associated Massive Transfusion: A Retrospective Cohort Study
Led by Zeliha Alicikus · Updated on 2026-04-14
4
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of prothrombin complex concentrate (PCC), recombinant activated factor VIIa (rFVIIa), both agents combined, or neither on trauma patients undergoing massive blood transfusion. The study aims to compare rates of blood clot complications and also examines secondary outcomes such as death rates, transfusion needs, lengths of stay in intensive care and hospitals, ventilator-free days, and risks of transfusion-related lung injury or circulatory overload. Subgroup analyses will explore differences between patients with and without trauma-induced coagulopathy confirmed by lab tests. The study groups include trauma patients receiving PCC during resuscitation, those receiving rFVIIa, patients treated with both PCC and rFVIIa, and a control group receiving standard resuscitation without these agents. Researchers will collect data retrospectively to assess how these treatments influence outcomes during massive transfusion. Participants are adult trauma patients admitted directly from the scene with severe injuries and who require massive transfusion defined by specific blood product volume thresholds. Data collection includes monitoring thromboembolic events over 28 days and tracking intensive care and hospital stays for the same period. The study will provide insights into treatment impacts, safety, and complications after trauma-associated massive transfusion.
CONDITIONS
Brief 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 18 years or older
- Trauma patients admitted directly from the scene with highest-level trauma activation and an Injury Severity Score (ISS) greater than 15
- Require massive transfusion defined as 3 or more units of packed red blood cells within the first hour or 10 or more units within the first 24 hours
You will not qualify if you...
- Traumatic cardiac injury
- Death anticipated within the first hour of admission with an ISS score greater than 49
- Use of anticoagulant therapy before injury
- Known pregnancy
- Pre-injury terminal illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants who undergo routine trauma care and massive transfusion are observed to evaluate outcomes related to Prothrombin Complex Concentrate (PCC), recombinant activated factor VIIa (rFVIIa), or their combination.
Ongoing observation during hospital stay up to 28 days
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
T
Tolga SARAÇOĞLU, Prof,MD
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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