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Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial
James Winearls1,2,3, Martin Wullschleger4,5, Elizabeth Wake4
1Gold Coast University Hospital, Southport, QLD, Australia. james.winearls@health.qld.gov.au.
Trials
|May 28, 2017
Summary
This pilot trial compares fibrinogen concentrate (FC) to cryoprecipitate (Cryo) for early fibrinogen replacement in severe trauma hemorrhage. Results will inform larger studies on optimal fibrinogen supplementation strategies.
Area of Science:
- Trauma and Emergency Medicine
- Hematology and Coagulation
- Clinical Trials and Research Methodology
Background:
- Hemorrhage in severe trauma is a leading cause of death.
- Fibrinogen is critical for hemostasis during traumatic hemorrhage.
- International guidelines recommend early fibrinogen replacement with either fibrinogen concentrate (FC) or cryoprecipitate (Cryo), but evidence comparing them is limited.
Purpose of the Study:
- To compare the feasibility and efficacy of fibrinogen concentrate (FC) versus cryoprecipitate (Cryo) for fibrinogen supplementation in traumatic hemorrhage.
- To provide data for designing a larger, more powerful clinical trial.
Main Methods:
- The Fibrinogen Early In Severe Trauma studY (FEISTY) is an exploratory, multicenter, randomized controlled trial.
- 100 adult trauma patients with hemorrhage will be randomized to receive either FC or Cryo.
- Thromboelastometry (ROTEM®) will guide fibrinogen supplementation dosing.
Main Results:
- Primary outcome: differential time to fibrinogen supplementation.
- Secondary outcomes: plasma fibrinogen levels, feasibility, transfusion requirements, and mortality.
Conclusions:
- The optimal method for fibrinogen replacement in traumatic hemorrhage remains debated.
- This pilot study will inform the design of future trials investigating patient-centered outcomes.
