Fibrinogen Treatments for Liver Transplant

(FITS Trial)

Recruiting at 2 trial locations

Overseen By Alisha Maslanka, BS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Ezeldeen Abuelkasem

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ezeldeen Abuelkasem, MBBCh, MSc

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for liver transplant patients who are experiencing bleeding and low fibrinogen levels (hypofibrinogenemia). Specific eligibility criteria details were not provided, so it's important to consult the study team for more information on who can participate.

Inclusion Criteria

I am scheduled for a liver transplant from a deceased donor.

I have low fibrinogen, alcoholic cirrhosis, NASH, or HCV infection.

I am 18 years old or older.

Exclusion Criteria

I have received a liver transplant from a donor after circulatory death.

I refuse to receive blood transfusions.

Known severe allergic reaction to plasma-based products

Treatment Details

Interventions

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

Trial Overview The study compares two treatments in liver transplant patients with bleeding: Investigational Cryoprecipitate Intercept Fibrinogen Complex (IFC) versus Standard Cryoprecipitate Antihemophilic Factor (AHF), focusing on how quickly they help blood clot.

Participant Groups

Group I: Investigational Cryoprecipitate Intercept Fibrinogen Complex (IFC) Experimental Treatment 1 Intervention

IFC is an approved plasma product that is not typically stored in the OR for liver transplant cases. Subjects assigned to this group will receive standard of care procedures, with the addition of IFC being readily available in their designated OR to eliminate any delay if they are to require the use of a plasma product.

Group II: Standard Cryoprecipitate Antihemophilic Factor (AHF) Active Control 1 Intervention

AHF is the standard of care plasma product often used in liver transplant cases. The procedures to implementing AHF include requesting the order of this plasma product and then waiting for the product to be thawed for use, which can take approximately 10-15 minutes. Subjects assigned to this group will receive all standard of care procedures, including the use of AHF if required during their scheduled surgery.

Who Is Running the Clinical Trial?

Ezeldeen Abuelkasem

Lead Sponsor

Trials

1

Recruited

30+