Fibrinogen in Liver Transplant Subjects

NCT ID: NCT06764927

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-03-01

Brief Summary

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.

Detailed Description

Fibrinogen is an important factor for hemostasis and when it is deficient or dysfunctional replacing it will improve hemostasis and reduce bleeding. Observational data indicates the use of cryoprecipitate as a source of fibrinogen may reduce bleeding and improve outcomes in patients with severe bleeding. Liver transplant patients often become hypofibrinogenemic and may benefit from early goal directed use of cryoprecipitate or IFC. IFC can be more readily available since it can be stored at room temperature compared to cryoprecipitate which requires thawing. As a result, IFC can be immediately available when indicated compared to the delay in administration of cryoprecipitate due to the need for it to be thawed. This trial will compare clinical outcomes for subjects randomized to either cryoprecipitate or IFC in bleeding liver transplant patients with reduced fibrinogen function.

There is no data comparing outcomes for subjects receiving IFC or cryoprecipitate in any patient population.

The rationale for this trial is to compare IFC to cryoprecipitate (cryo) to assist with the design of a future definitice multicenter trial. Potential advantages of IFC are that since it is stored at room temperature it can be made immediatwlt available whereas with cryo the delay in treatment can be 30 to 40 min due to the need to thaw it from a frozen state. The reduced time to treatment of bleeding may improve outcomes with the use of IFC compared to cryo. In vitro data indicates similar hemostatic function between IFC and Cryo. IFC is pathogen reduced cryoprecipitate. The pathogen reduction methods are licensed for IFC and there has been no safety concerns regarding its use at the centers that are currently using it as their standard product (unpublished).

Conditions

Liver Transplant Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Cryoprecipitate Antihemophilic Factor (AHF)

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.

Group Type: ACTIVE_COMPARATOR

Cryoprecipitate Antihemophilic Factor (AHF)

Intervention Type: BIOLOGICAL

Cryoprecipitate Antihemophilic Factor (AHF), also known as cryo, is a frozen blood product prepared from blood plasma. It is used for fibrinogen supplementation, particularly for hypofibrinogenemia fibrinogen, anemia associated with bleeding or congenital deficiency.

Investigational Cryoprecipitate Intercept Fibrinogen Complex (IFC)

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 Type: ACTIVE_COMPARATOR

Cryoprecipitate Intercept Fibrinogen Complex (IFC)

Intervention Type: BIOLOGICAL

INTERCEPT Fibrinogen Complex is a pathogen-reduced cryoprecipitated fibrinogen complex derived from human plasma. It contains fibrinogen, Factor XIII, and von Willebrand factor to achieve stable clot formation and restore hemostasis1. Recently approved by the US Food and Drug Administration, it is used for the treatment of bleeding associated with fibrinogen deficiency.

Interventions

Cryoprecipitate Intercept Fibrinogen Complex (IFC)

INTERCEPT Fibrinogen Complex is a pathogen-reduced cryoprecipitated fibrinogen complex derived from human plasma. It contains fibrinogen, Factor XIII, and von Willebrand factor to achieve stable clot formation and restore hemostasis1. Recently approved by the US Food and Drug Administration, it is used for the treatment of bleeding associated with fibrinogen deficiency.

Intervention Type: BIOLOGICAL

Cryoprecipitate Antihemophilic Factor (AHF)

Cryoprecipitate Antihemophilic Factor (AHF), also known as cryo, is a frozen blood product prepared from blood plasma. It is used for fibrinogen supplementation, particularly for hypofibrinogenemia fibrinogen, anemia associated with bleeding or congenital deficiency.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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
• Alcoholic cirrhosis
• Nonalcoholic Steatohepatitis (NASH)
• HCV infection

Exclusion Criteria

• Living related donor transplant
• DCD liver recipient
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ezeldeen Abuelkasem

OTHER

Sponsor Role: lead

Responsible Party

Ezeldeen Abuelkasem

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ezeldeen Abuelkasem, MBBCh, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Cincinnati

Cincinnati, Ohio, United States

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, United States

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Central Contacts

Ezeldeen Abuelkasem, MBBCh, MSc

Role: CONTACT

abuelkaseme@upmc.edu

(412) 648-6077

Alisha Maslanka, BS

Role: CONTACT

maslankaaa@upmc.edu

412-491-2748

Facility Contacts

Ezeldeen Abuelkasem, MBBCh, MSc

Role: primary

Ezeldeen Abuelkasem, MBBCh, MSc

Role: primary

abuelkaseme@upmc.edu

(412) 648-6077

Alisha Maslanka, BS

Role: backup

maslankaaa@upmc.edu

412-491-2748

Ezeldeen Abuelkasem, MBBCh, MSc

Role: primary

abuelkaseme@upmc.edu

(412) 648-6077

Alisha Maslanka, BS

Role: backup

maslankaaa@upmc.edu

412-491-2748

Other Identifiers

STUDY24070113

Identifier Type: -

Identifier Source: org_study_id