Fibrinogen in Liver Transplant Study

This study is looking at two different treatments, Intercept Fibrinogen Complex (IFC) and Cryoprecipitate Antihemophilic Factor (AHF), for patients undergoing liver transplant surgery who have bleeding and low fibrinogen (a protein important for blood clotting). The goal is to see if IFC, which can be given more quickly, works as well as AHF in reducing the amount of blood products needed. You might be able to join if you are 18 or older, scheduled for a cadaveric liver transplant, and have certain conditions like low fibrinogen or alcoholic cirrhosis. The study is currently recruiting participants.

Study design
This is a pilot study that will randomly assign participants to receive either Intercept Fibrinogen Complex (IFC) or Cryoprecipitate Antihemophilic Factor (AHF). It will include about 60 participants and is not blinded, meaning both you and your doctors will know which treatment you are receiving.
What's involved
The main measurement for this study is the amount of blood products you receive within 24 hours after the initial blood product administration.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of the study is measured 24 hours after the initial blood product administration.

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NCT07265843

Fibrinogen in Liver Transplant

Not Yet Recruiting
PHASE4Ages 18+InterventionalTreatment
Trauma Hemostatis and Oxygenation Research (THOR) Network
~60 participants
Updated 2025-12-05 on ClinicalTrials.gov
What's tested:Intercept Fibrinogen Complex (IFC)Cryoprecipitate Antihemophilic Factor (AHF)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Amount of blood products (24-hours) [Time Frame: 24-hours after initial blood product administration]
Measured over 24-hour
Liver Transplant Surgery
1 sites across 1 states
Ohio1

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Eligibility criteria

Inclusion

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

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

    The amount of blood products (mL) administered will be collected at the 24-hour timepoint per intervention group and reported as the mean (mL).