Not Yet RecruitingPhase 4

Fibrinogen in Liver Transplant

United States60 participantsStarted 2026-01-01

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 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.

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 or clinically significant visoelastic testing, * Alcoholic cirrhosis, * 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

What they're measuring

Amount of blood products (24-hours) [Time Frame: 24-hours after initial blood product administration]

Timeframe: 24-hour

Trial details

NCT IDNCT07265843

SponsorTrauma Hemostatis and Oxygenation Research (THOR) Network

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-01

Contact for this trial

Meghan Huff Research Nurse, BSN

6185789309 mhuff@pitt.edu

View on ClinicalTrials.gov More Liver Transplant Surgery trials