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Fibrinogen in Liver Transplant Subjects
Sponsor: Ezeldeen Abuelkasem
Summary
The study is a prospective, multi-centered, unblinded, randomized controlled pilot study. The primary objective is to compare functional hemostatic capacity of Investigational Cryoprecipitate 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-10-31
Completion Date
2026-03-01
Last Updated
2025-08-12
Healthy Volunteers
No
Conditions
Interventions
Cryoprecipitate 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 hemostasis1. 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 (3)
University of Cincinnati
Cincinnati, Ohio, United States
UPMC Montefiore Hospital
Pittsburgh, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States