Fibrinogen in Liver Transplant

Официальное название

Fibrinogen in Liver Transplant Subjects (FITS)

Обзор

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.

Подробное описание

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has been no safety concerns regarding its use at the centers that are currently using it as their standard product (unpublished).

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (3)

• Change in Visoelastic parameters [Time Frame: pre-intervention through 24 hours post intervention] [Срок оценки: pre intervention through 24 hours post intervention]
• Costs of blood products [Time Frame: 24 hours] [Срок оценки: 24 hours post-surgery]
• Costs of IV hemostatic agents [Time Frame: 24 hours] [Срок оценки: 24 hours post-surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Cincinnati — Cincinnati

Идентификаторы

NCT: NCT07265843 · FITS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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