Fibrinogen in Liver Transplant Subjects

NCT06764927 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: STUDY24070113
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Liver Transplant Surgery

Outcome Measures

Primary Outcomes (1)

• Amount of blood products (24-hours)

  The amount of blood products (mL) administered will be collected at the 24-hour timepoint per intervention group and reported as the mean (mL).

  24-hours after initial blood product administration

Secondary Outcomes (3)

• Change in TEG parameters

  14 days post-surgery

• Costs of blood products

  14 days post-surgery

• Costs of IV hemostatic agents

  14 days post-surgery

Study Arms (2)

Standard Cryoprecipitate Antihemophilic Factor (AHF)

ACTIVE COMPARATOR

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.

Biological: Cryoprecipitate Antihemophilic Factor (AHF)

Investigational Cryoprecipitate Intercept Fibrinogen Complex (IFC)

ACTIVE COMPARATOR

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.

Biological: Cryoprecipitate Intercept Fibrinogen Complex (IFC)

Interventions

Cryoprecipitate Antihemophilic Factor (AHF) 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.

Standard Cryoprecipitate Antihemophilic Factor (AHF)

Cryoprecipitate Intercept Fibrinogen Complex (IFC) 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.

Investigational Cryoprecipitate Intercept Fibrinogen Complex (IFC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ezeldeen Abuelkasem: lead

Study Sites (3)

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

• Ezeldeen Abuelkasem, MBBCh, MSc

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: N/A - unblinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospective, multi-center, unblinded, randomized controlled study.

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 9, 2025
• Study Start: January 31, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD sharing will occur up to the anticipated study completion in March 2026
• Access Criteria: IRB-approved investigators at the University of Pittsburgh will be the only research personnel with access to all of the IPD and supporting information.

Locations

US (3)