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RECRUITING Phase 4 ClinicalTrials.gov

Fibrinogen in Liver Transplant

Sponsor: Trauma Hemostatis and Oxygenation Research (THOR) Network • ClinicalTrials.gov ID: NCT07265843

Registry updated: 2026-10-19
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Description

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.

Interventions

  • Intercept Fibrinogen Complex (IFC) (Biological)
    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) (Biological)
    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.

Eligibility criteria

Inclusion Criteria: * 18 years of age or older * Scheduled to undergo cadaveric liver transplant * Meets at least one of the following criteria: Baseline fibrinogen \<200 mg/dL or clinically significant visoelastic testing * Meets any one of the following criteria: Alcoholic cirrhosis, Metabolic dysfunction associated steatohepatitis (MASH) (previously known as Nonalcoholic Steatohepatitis (NASH)), HCV infection Exclusion Criteria: * Living related donor transplant, * Known prothrombotic disorder, * Patient objection to blood transfusion, * Known severe allergic reaction to plasma-based products, * IgA deficiency with known hypersensitivity reaction to plasma, * Hepatocellular/cholangio carcinoma, * Primary biliary fibrosis * Active bleeding prior to the operation

Conditions

Liver Transplant Surgery

Locations

  • University of Cincinnati — Cincinnati, Ohio, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record