No supply of the test substance was provided by the sponsor.

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.

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has been no safety concerns regarding its use at the centers that are currently using it as their standard product (unpublished).

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

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 will occur up to the anticipated study completion in March 2026

IRB-approved investigators at the University of Pittsburgh will be the only research personnel with access to all of the IPD and supporting information.

N/A - unblinded