Fibrinogen in Liver Transplant Subjects (FITS)
Trauma Hemostatis and Oxygenation Research (THOR) Network
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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, *…
Interventions
- BiologicalIntercept 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 hemostasis. Recently approved by the US Food and Drug Administration, it is used for the treatment of bleeding associated with fibrinogen deficiency.
- BiologicalCryoprecipitate 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.
Location
- University of CincinnatiCincinnati, Ohio