Fibrinogen Treatment for Liver Transplant

Overseen By Meghan Huff Research Nurse, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Trauma Hemostatis and Oxygenation Research (THOR) Network

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: 1

Duration: During surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments to manage bleeding during liver transplants. It compares Intercept Fibrinogen Complex (IFC), which can be used immediately, with the standard Cryoprecipitate Antihemophilic Factor (AHF), which requires brief preparation. The goal is to determine if faster access to fibrinogen (a protein that aids blood clotting) can improve outcomes for liver transplant patients with bleeding issues. Suitable candidates include those with conditions like alcoholic cirrhosis or hepatitis C who are scheduled for a liver transplant. As a Phase 4 trial, this research involves treatments already FDA-approved and proven effective, aiming to understand how they benefit more patients.

What is the safety track record for Intercept Fibrinogen Complex (IFC) and Cryoprecipitate Antihemophilic Factor (AHF)?

Research has shown that Intercept Fibrinogen Complex (IFC) is generally easy for patients to handle. One study found that IFC reduced the time from ordering to receiving the treatment by 58%, making it quick to use during surgeries. This speed can be crucial when time is critical, such as in liver transplants. Another study in heart surgeries suggested that IFC effectively controls bleeding during operations.

Both IFC and the standard Cryoprecipitate Antihemophilic Factor (AHF) have FDA approval, indicating they have been tested for safety. While specific side effects are not detailed in the available sources, their approval suggests they meet safety standards. However, discussing any concerns with the trial team or a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Intercept Fibrinogen Complex (IFC) because it offers a faster and more efficient alternative to the standard Cryoprecipitate Antihemophilic Factor (AHF) used in liver transplants. Unlike AHF, which requires thawing time before use, IFC is readily available in the operating room, eliminating delays and potentially improving patient outcomes during surgery. This immediacy can be crucial in critical situations where time is of the essence, making IFC a promising option for enhancing the standard care in liver transplants.

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

In this trial, participants will receive either Intercept Fibrinogen Complex (IFC) or Cryoprecipitate Antihemophilic Factor (AHF) during liver transplant procedures. Research has shown that IFC can significantly speed up treatment, reducing wait time from about 30 minutes to just under 15 minutes. Quick access to fibrinogen, a protein that aids in blood clotting, is crucial during liver transplants to control bleeding. Studies have found that low fibrinogen levels can lead to severe bleeding and increase the risk of death. IFC is designed to rapidly provide fibrinogen, potentially improving patient outcomes by making this vital blood component available more quickly. This suggests that using IFC might help manage bleeding more effectively in liver transplant patients. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for liver transplant patients who are bleeding and have low fibrinogen levels (hypofibrinogenemia). It's a pilot study to see which treatment helps control bleeding better during surgery.

Inclusion Criteria

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

I am 18 years old or older.

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

Exclusion Criteria

IgA deficiency with known hypersensitivity reaction to plasma

Living related donor transplant

Known prothrombotic disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Intercept Fibrinogen Complex (IFC) or Standard Cryoprecipitate Antihemophilic Factor (AHF) during liver transplant surgery to manage bleeding and hypofibrinogenemia

During surgery

1 visit (in-person)

Immediate Post-operative Monitoring

Participants are monitored for the amount of blood products administered and changes in viscoelastic parameters within 24 hours post-intervention

24 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The trial compares two treatments: Intercept Fibrinogen Complex (IFC) and Standard Cryoprecipitate Antihemophilic Factor (AHF). Patients will be randomly assigned to receive one of these products to manage bleeding during their liver transplant.

How Is the Trial Designed?

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

AHF is the standard of care fibrinogen product often used in liver transplant cases. The procedures to use AHF include requesting the order of this 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.

Group II: Intercept Fibrinogen Complex (IFC) Active Control 1 Intervention

IFC is an approved fibrinogen 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 fibrinogen product.

Who Is Running the Clinical Trial?

Trauma Hemostatis and Oxygenation Research (THOR) Network

Lead Sponsor

Citations

1. 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.

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/trf.17774

Analyzing and modeling massive transfusion strategies ... Fibrinogen level below 200 mg dL−1 is an independent risk factor for severe hemorrhage in trauma, cardiovascular, liver transplant, and ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38967047/

Implementation and early outcomes with Pathogen ... Conclusions: There has been a substantial decrease in waste with improved turnaround time after IFC implementation. This has improved blood bank ...

4. intercept-usa.com intercept-usa.com/wp-content/uploads/2024/05/AABB23-Poster-P-TS-40-Stanford-Implementation-and-Quality-Analysis-of-PRCFC-STAMPED.pdf

Implementation & Quality Analysis of Pathogen Reduced ... There is also evidence that suggests low fibrinogen levels are associated with higher rates of mortality in traumatic bleeding and there may be a potential ...

5. researchgate.net researchgate.net/publication/382021885_Implementation_and_early_outcomes_with_Pathogen_Reduced_Cryoprecipitated_Fibrinogen_Complex

Implementation and early outcomes with Pathogen ... A single-center study indicated that use of Intercept Fibrinogen Complex reduced time from order to treatment by 58% (30.4 to 14.6 minutes).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11430273/

Trial Of Pathogen-reduced Cryoprecipitate vs ... This trial aims to provide evidence of the clinical efficacy of utilizing readily available thawed IFC during acute bleeding in the cardiac surgery setting

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05711524

Study Details | NCT05711524 | Transfusion of Pathogen ... Immediately replacing fibrinogen in perioperative bleeding patients with acquired fibrinogen deficiency improves outcomes. The product that is primarily used ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/trf.18434

Variable practices observed from July 2016 to June 2021, ... Cryo production and usage data were collected over 5 years from July 1, 2016, to June 30, 2021, from nationally based blood collection centers ...