Fibrinogen Treatments for Liver Transplant

(FITS Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for liver transplant patients with bleeding issues and low fibrinogen levels, a protein that aids blood clotting. The goal is to determine if a new product, Intercept Fibrinogen Complex (IFC), can outperform the usual treatment, Cryoprecipitate Antihemophilic Factor (AHF), by providing faster fibrinogen access during surgery. Suitable candidates for this trial include those undergoing a liver transplant due to conditions like alcoholic cirrhosis or hepatitis C and who have low fibrinogen levels. As a Phase 4 trial, this study involves an FDA-approved treatment, aiming to understand how it can benefit more patients.

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.

What is the safety track record for these treatments?

A previous study showed that the Cryoprecipitate Intercept Fibrinogen Complex (IFC) speeds up treatment times by reducing the wait from order to treatment by 58%. This allows patients to receive help faster when bleeding. Another study found that using cryoprecipitate, like IFC, can reduce bleeding and improve outcomes in severe cases, suggesting IFC is well-tolerated and effective in emergencies.

In contrast, Cryoprecipitate Antihemophilic Factor (AHF) has been used for nearly 50 years to manage bleeding, especially in individuals with hemophilia A. It is a standard treatment generally considered safe, though some patients have experienced allergic reactions.

Both treatments aim to manage bleeding by providing fibrinogen, a protein that aids blood clotting. The long history of AHF and the promising early results for IFC suggest these treatments are generally safe for use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they offer potentially faster and more accessible options for managing bleeding during liver transplants. The Cryoprecipitate Intercept Fibrinogen Complex (IFC) is unique because it can be stored in the operating room, eliminating the usual wait time needed to thaw the standard Cryoprecipitate Antihemophilic Factor (AHF). This prompt availability of IFC could help reduce delays in critical situations, offering a more efficient response compared to the current standard of care. By having IFC readily available, it's possible to improve patient outcomes by minimizing bleeding complications more swiftly during surgery.

What evidence suggests that this trial's treatments could be effective for liver transplant patients?

Research has shown that cryoprecipitate, which provides fibrinogen, can reduce bleeding and improve outcomes in patients with severe bleeding. In this trial, participants will receive one of two treatments. The Investigational Cryoprecipitate Intercept Fibrinogen Complex (IFC) is a special product that might improve blood clotting more effectively than standard treatments. Observational studies suggest that using cryoprecipitate during surgeries can be beneficial. The standard Cryoprecipitate Antihemophilic Factor (AHF) is already known to assist when blood doesn't clot properly. Both treatments aim to increase fibrinogen levels, helping to control bleeding during liver transplants. ^{1 2 4 6 7}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3019540/

Outcome of liver transplantation for haemophilia - PMC At a median follow-up of 90 months, 8 patients have died, including 4 of the 5 patients that were HIV positive. The median survival of patients with and without ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06764927

NCT06764927 | Fibrinogen in Liver Transplant Subjects Observational data indicates the use of cryoprecipitate as a source of fibrinogen may reduce bleeding and improve outcomes in patients with severe bleeding.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4627369/

Cryoprecipitate therapy - PMC - PubMed Central - NIH Although cryoprecipitate improved coagulopathy, 4 U FFP were more efficacious, produced a significantly greater improvement in international normalized ratio ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1538783622037710

Liver transplantation as a novel strategy for resolution of ... A growing body of evidence shows HFCs to be safe and effective11., 12., 13., 14., 15.; however, allergic or hypersensitivity reactions, seen with other ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/pdf/10.1111/trf.17774

Analyzing and modeling massive transfusion strategies ... Abstract. Background: Hemorrhage is a leading cause of preventable death in trauma, cardiac surgery, liver transplant, and childbirth.

6. caep.ca caep.ca/periodicals/Volume_22_Issue_Supplement_2/Vol_22_Issue_Supplement_2_Page_S4_-_S11_Nascimento.pdf

Cryoprecipitate transfusion in bleeding patients Intraoperative cryoprecipitate transfusion was inde- pendently associated with biliary complications follow- ing liver transplantation (relative risk, 3.46; p < ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10692241/

rFVIIIFc in hemophilia A and liver transplantation - PMC These results support the efficacy and safety results known from other studies performed with extended half-life FVIII products [3].