WithdrawnPhase 4

Fibrinogen in Liver Transplant Subjects

Stopped: No supply of the test substance was provided by the sponsor.

United States0Started 2026-01-31

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Alcoholic cirrhosis * Nonalcoholic Steatohepatitis (NASH) * HCV infection Exclusion Criteria: * Living related donor transplant * DCD liver recipient * 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

What they're measuring

Amount of blood products (24-hours)

Timeframe: 24-hours after initial blood product administration

Trial details

NCT IDNCT06764927

SponsorEzeldeen Abuelkasem

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-01

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