Recruiting
Phase 4

IFC vs. AHF

Sponsor:

Trauma Hemostatis and Oxygenation Research (THOR) Network

Code:

NCT07265843

Conditions

Liver Transplant Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intercept Fibrinogen Complex (IFC)

Cryoprecipitate Antihemophilic Factor (AHF)

Study Details

Brief 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.

Conditions

Liver Transplant Surgery

Study ID

NCT07265843

Start date

May 21, 2026

Status verified date

Oct, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
  • Meets any one of the following criteria: Alcoholic cirrhosis, Metabolic dysfunction associated steatohepatitis (MASH) (previously known as 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
  • Active bleeding prior to the operation

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Meghan Huff Research Nurse, BSN

6185789309mhuff@pitt.edu

Locations

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45221

Contacts

Ralph Quillin

513-558-3993quillirc@ucmail.uc.edu

More Information

Sponsor

Trauma Hemostatis and Oxygenation Research (THOR) Network

Last update posted

Oct 19, 2026

Last verified

Oct, 2026

Keywords

  • Cryoprecipitate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-20. This information was provided to ClinicalTrials.gov by Trauma Hemostatis and Oxygenation Research (THOR) Network on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.