Clinical trial NCT06764927: Fibrinogen in Liver Transplant Subjects
Official title: Fibrinogen in Liver Transplant Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Liver Transplant Surgery
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multi-center, unblinded, randomized controlled pilot study.
Primary purpose: TREATMENT

Brief summary: The study is a prospective, multi-centered, unblinded, randomized controlled pilot study. The primary objective is to compare functional hemostatic capacity of Investigational Cryoprecipitate 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.

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

Eligibility criteria: 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
* Alcoholic cirrhosis
* Nonalcoholic Steatohepatitis (NASH)
* HCV infection

Exclusion Criteria:

* Living related donor transplant
* DCD liver recipient
* 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

Primary outcomes:
measure: Amount of blood products (24-hours)
timeFrame: 24-hours after initial blood product administration
Secondary outcomes:
measure: Change in TEG parameters
timeFrame: 14 days post-surgery
measure: Costs of blood products
timeFrame: 14 days post-surgery
measure: Costs of IV hemostatic agents
timeFrame: 14 days post-surgery
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Montefiore Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ezeldeen Abuelkasem, MBBCh, MSc
role: PRINCIPAL_INVESTIGATOR
References: