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NCT Number: NCT07265843

Fibrinogen in Liver Transplant

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.

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Key information

Conditions

Liver Transplant Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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 definitive multicenter trial. Potential advantages of IFC are that since it is stored at room temperature it can be made immediately 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 24-hour

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

Secondary outcomes

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

    Time frame: pre intervention through 24 hours post intervention

    Change in Visoelastic 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.

  2. Costs of blood products [Time Frame: 24 hours]

    Time frame: 24 hours post-surgery

    The costs (USD) of blood products used per intervention group will be collected 24 hours post-surgery and reported as the mean (USD).

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

    Time frame: 24 hours post-surgery

    The costs (USD) of IV hemostatic agents used per intervention group will be collected 24 hours post-surgery and reported as the mean (USD).

Study contacts

Contact information is provided by the study sponsor or research team.

Meghan Huff Research Nurse, BSN

CONTACT

[email protected]

6185789309

Sponsors and collaborators

Lead sponsor

Trauma Hemostatis and Oxygenation Research (THOR) Network

Other

Registry information

Official study title

Fibrinogen in Liver Transplant Subjects (FITS)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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