Fibrinogen in Liver Transplant

NCT07265843 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: FITS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a prospective, multi-centered, unblinded, randomized controlled pilot study. The primary objective is to compare functional hemostatic capacity of two approved products 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

Keywords

Cryoprecipitate

Outcome Measures

Primary Outcomes (1)

• Amount of blood products (24-hours) [Time Frame: 24-hours after initial blood product administration]

  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-hour

Secondary Outcomes (3)

• Change in Visoelastic parameters [Time Frame: pre-intervention through 24 hours post intervention]

  pre intervention through 24 hours post intervention

• Costs of blood products [Time Frame: 24 hours]

  24 hours post-surgery

• Costs of IV hemostatic agents [Time Frame: 24 hours]

  24 hours post-surgery

Study Arms (2)

Standard Antihemophilic Factor (AHF)

ACTIVE COMPARATOR

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.

Biological: Cryoprecipitate Antihemophilic Factor (AHF)

Intercept Fibrinogen Complex (IFC)

ACTIVE COMPARATOR

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.

Biological: Intercept Fibrinogen Complex (IFC)

Interventions

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 hemostasis. Recently approved by the US Food and Drug Administration, it is used for the treatment of bleeding associated with fibrinogen deficiency.

Intercept Fibrinogen Complex (IFC)

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 Antihemophilic Factor (AHF)

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 or clinically significant visoelastic testing,
• Alcoholic cirrhosis,
• Nonalcoholic Steatohepatitis (NASH),
• HCV infection

You may not qualify if:

• Living related donor transplant,
• 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

• Trauma Hemostatis and Oxygenation Research (THOR) Network: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

Central Study Contacts

Meghan Huff Research Nurse, BSN

CONTACT

6185789309; mhuff@pitt.edu

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

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

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 5, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (1)