Fibrinogen in Liver Transplant: Can a concentrated product help bleeding patients.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized pilot study in adults undergoing cadaveric liver transplant who have low fibrinogen or abnormal viscoelastic tests. Participants are randomly assigned to receive Intercept Fibrinogen Complex (IFC) or standard cryoprecipitate during bleeding episodes. The study aims to see if IFC’s ready availability at room temperature can shorten time to treatment and improve hemostatic outcomes. It is unblinded and focused on short-term clinical outcomes in the transplant setting. Data from this pilot will inform the design of a larger definitive trial.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Cincinnati
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: Meghan Huff Research Nurse, BSN
• Email: mhuff@pitt.edu
• Phone: 6185789309

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dexcom G7 CGM in critically ill adults after major abdominal surgery or solid organ transplant

  This study tests how accurately the Dexcom G7 continuous glucose monitor tracks glucose in ICU patients after major abdominal surgery or solid organ transplantation who need tight insulin control.

  Recruiting Institute for Clinical and Experimental Medicine · Prague · NCT07611721

• Preoperative Carbohydrate Loading Before Liver Transplant

  This study tests whether drinking a carbohydrate beverage before anesthesia helps liver transplant patients recover faster.

  Recruiting Medical University of Warsaw · Warsaw · NCT07519057

• Combining radiotherapy and immunotherapy for advanced liver cancer before transplant

  This study is testing if combining radiation therapy with immunotherapy can help people with advanced liver cancer get better and qualify for a liver transplant.

  Recruiting Phase 1/2 University Health Network, Toronto · London, Ontario and 1 other locations · NCT06725121

• Comparing liver transplant methods for colorectal cancer patients

  This study is testing different liver transplant methods for colorectal cancer patients to see which one helps them recover faster and live longer after the surgery.

  Recruiting Northwestern University · Chicago, Illinois · NCT06698146

• Expanding HIV-positive donor livers for HIV-positive recipients

  This study tests whether liver transplants from HIV-positive donors to HIV-positive recipients are safe regarding opportunistic infections and cancer.

  Recruiting at 2 sites National Institute of Allergy and Infectious Diseases (NIAID) · Baltimore, Maryland and 1 other locations · NCT07778459

• Magnetic Resonance Cholangiopancreatography to help living liver donors and their recipients

  This study tests whether preoperative MRCP imaging can help select living liver donors and reduce biliary complications in recipients.

  Recruiting Institute of Liver and Biliary Sciences, India · New Delhi · NCT07715500

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.