Liver Transplant Surgery
Conditions
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has been no safety concerns regarding its use at the centers that are currently using it as their standard product (unpublished).
Interventions
BIOLOGICALCryoprecipitate 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 hemostasis1. 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), 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.
Sponsors
Ezeldeen Abuelkasem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
N/A - unblinded
Intervention model description
Prospective, multi-center, unblinded, randomized controlled study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of blood products (24-hours) | 24-hours after initial blood product administration | The amount of blood products (mL) administered will be collected at the 24-hour timepoint per intervention group and reported as the mean (mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in TEG parameters | 14 days post-surgery | Change in TEG parameters, in particular the % change in the alpha angle will be calculated for each study participant and the effect size of the differences in the change, and 95% confidence interval. |
| Costs of blood products | 14 days post-surgery | The costs (USD) of blood products used per intervention group will be collected 14-days post-surgery and reported as the mean (USD). |
| Costs of IV hemostatic agents | 14 days post-surgery | The costs (USD) of IV hemostatic agents used per intervention group will be collected 14-days post-surgery and reported as the mean (USD). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREzeldeen Abuelkasem, MBBCh, MSc
University of Pittsburgh
Outcome results
None listed