Fibrinogen in Liver Transplant Subjects (FITS)

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.

Study Overview

• Status: Withdrawn
• Conditions: Liver Transplant Surgery
• Intervention / Treatment: Biological: Cryoprecipitate Antihemophilic Factor (AHF); Biological: Cryoprecipitate Intercept Fibrinogen Complex (IFC)

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).

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45221
      • University of Cincinnati
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Montefiore Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in TEG parameters	Change in TEG parameters, in particular the % change in the alpha angle will be calculated for each study participant and the effect size of the differences in the change, and 95% confidence interval.	14 days post-surgery
Costs of blood products	The costs (USD) of blood products used per intervention group will be collected 14-days post-surgery and reported as the mean (USD).	14 days post-surgery
Costs of IV hemostatic agents	The costs (USD) of IV hemostatic agents used per intervention group will be collected 14-days post-surgery and reported as the mean (USD).	14 days post-surgery

Collaborators and Investigators

• Sponsor: Ezeldeen Abuelkasem
• Investigators: Principal Investigator: Ezeldeen Abuelkasem, MBBCh, MSc, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Estimated): January 31, 2026
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): January 9, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coagulants; Factor VIII
• Other Study ID Numbers: STUDY24070113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data from the participating site, University of Cincinnati College of Medicine, will be shared with Pitt.

In the future, the investigators may decide to share data with other investigators both within and outside of the institution. If this were to occur, we would de-identify all of the information prior to sharing data in this way. The Office of Sponsored Programs will be contacted prior to sharing data to determine if a date use agreement is necessary.

• IPD Sharing Time Frame: IPD sharing will occur up to the anticipated study completion in March 2026
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No