Fibrinogen in Liver Transplant

Conditions

• Liver Transplant Surgery

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Jan 1, 2026

Status verified

Dec 2025

Primary completion

Mar 1, 2028

Completion

Mar 1, 2028

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Standard Antihemophilic Factor (AHF)
  AHF is the standard of care fibrinogen product often used in liver transplant cases. The procedures to use AHF include requesting the order of this 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.
• Active Comparator: Intercept Fibrinogen Complex (IFC)
  IFC is an approved fibrinogen 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 fibrinogen product.

Primary Outcome Measure

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

Central Contacts

• Meghan Huff Research Nurse, BSN
  6185789309
  [email protected]

Locations (1)

Find similar trials in Cincinnati, OH

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