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Fibrinogen in Liver Transplant
Sponsor: Trauma Hemostatis and Oxygenation Research (THOR) Network
Summary
The study is a prospective, multi-centered, unblinded, randomized controlled pilot study. The primary objective is to compare functional hemostatic capacity of two approved products Intercept Fibrinogen Complex (IFC) to Standard Cryoprecipitate Antihemophilic Factor (AHF) for liver transplant patients with bleeding and hypofibrinogenemia to determine impact of earlier access to a concentrated source of fibrinogen in a goal-directed manner.
Official title: Fibrinogen in Liver Transplant Subjects (FITS)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-01-01
Completion Date
2028-03-01
Last Updated
2025-12-05
Healthy Volunteers
No
Conditions
Interventions
Intercept Fibrinogen Complex (IFC)
INTERCEPT Fibrinogen Complex is a pathogen-reduced cryoprecipitated fibrinogen complex derived from human plasma. It contains fibrinogen, Factor XIII, and von Willebrand factor to achieve stable clot formation and restore hemostasis. Recently approved by the US Food and Drug Administration, it is used for the treatment of bleeding associated with fibrinogen deficiency.
Cryoprecipitate Antihemophilic Factor (AHF)
Cryoprecipitate Antihemophilic Factor (AHF), also known as cryo, is a frozen blood product prepared from blood plasma. It is used for fibrinogen supplementation, particularly for hypofibrinogenemia fibrinogen, anemia associated with bleeding or congenital deficiency.
Locations (1)
University of Cincinnati
Cincinnati, Ohio, United States