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Fibrinogen in Liver Transplant

RecruitingPhase 4Ages 18 Years - anyAllTrauma Hemostatis and Oxygenation Research (THOR)…
NCT07265843 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Intercept Fibrinogen Complex (IFC)
  • Cryoprecipitate Antihemophilic Factor (AHF)
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Where

1 site
University of Cincinnati
Cincinnati, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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