Fibrinogen Treatments for Liver Transplant

(FITS Trial)

Recruiting at 2 trial locations

Overseen By Alisha Maslanka, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Ezeldeen Abuelkasem

Disqualifiers: Prothrombotic disorder, Blood transfusion objection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: During surgery

30 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is cryoprecipitate safe for use in liver transplant patients?

Cryoprecipitate has been used in liver transplant surgeries to manage bleeding, and studies show it does not significantly increase the risk of major blood clots compared to other treatments. However, it may be associated with complications like pulmonary edema (fluid in the lungs) in some patients. ^{1 2 3 4 5}

How is the treatment Cryoprecipitate Antihemophilic Factor (AHF), Cryoprecipitate Intercept Fibrinogen Complex (IFC) unique for liver transplant patients?

This treatment is unique because it specifically targets hypofibrinogenemia (low levels of fibrinogen, a blood clotting protein) during liver transplantation, which is crucial for managing massive bleeding. Unlike other treatments, cryoprecipitate provides a concentrated source of fibrinogen, which is essential for clot formation, without causing significant volume overload, making it particularly useful in the surgical setting of liver transplants. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment Cryoprecipitate Antihemophilic Factor (AHF), Cryoprecipitate Intercept Fibrinogen Complex (IFC) for liver transplant?

Cryoprecipitate is commonly used to manage bleeding during liver transplants by addressing low fibrinogen levels, which are crucial for blood clotting. Studies show that cryoprecipitate is effective in treating coagulopathy (a condition where the blood's ability to clot is impaired) during liver transplants, although its specific impact on complications like biliary issues is not well-documented. ^{1 2 3 4 6}

Who Is on the Research Team?

Ezeldeen Abuelkasem, MBBCh, MSc

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Investigational Cryoprecipitate Intercept Fibrinogen Complex (IFC) or Standard Cryoprecipitate Antihemophilic Factor (AHF) during liver transplant surgery

During surgery

Immediate Post-operative Monitoring

Participants are monitored for the amount of blood products administered within 24 hours post-surgery

24 hours

Follow-up

Participants are monitored for changes in TEG parameters and costs of blood products and IV hemostatic agents

14 days

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

Group I: Investigational Cryoprecipitate Intercept Fibrinogen Complex (IFC) Active Control 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+

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Prothrombin Complex Concentrate in Liver Transplant Surgery: Correction of Therapeutic Anticoagulation and the Coagulopathy of End-Stage Liver Disease: Case Series. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Intraoperative cryoprecipitate transfusion and its association with the incidence of biliary complications after liver transplantation--a retrospective cohort study. [2021]

3. Turkey pubmed.ncbi.nlm.nih.gov

Administering RiaSTAP for Congenital Afibrinogenemia During Liver Transplant. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of Fibrinogen Concentrate and Cryoprecipitate on Major Thromboembolic Events after Living Donor Liver Transplantation. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Coagulopathy of Liver Disease. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Cryoprecipitate for the correction of coagulopathy associated with liver disease. [2019]