Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-24 @ 3:32 PM
NCT ID:
NCT04531592
Eligibility Criteria:
Inclusion Criteria:
* Is aged 18 to 80 years old;
* Is male or non-pregnant, non-breastfeeding female;
* Is able to provide written informed consent or has an LAR from whom consent can be obtained;
* Body mass index (BMI) is between 18 kg/m2 and 35 kg/m2;
* Expected transfusion of 3 or more units of red cell product, as determined by the patient's provider; and
* Is scheduled to undergo liver transplant surgery without hepatocellular carcinoma (HCC) exception points.
Exclusion Criteria:
* Has a known history of adverse reaction to VPA;
* Is currently receiving VPA;
* Is pregnant or breastfeeding;
* Is in need of a simultaneous kidney transplant, or currently on RRT for either AKI or hepato-renal syndrome, type I (HRS-I);
* Is currently incarcerated or pending incarceration;
* Is known to have mitochondrial disorders caused by polymerase γ (POLG) mutations;
* Has acute liver failure;
* Has porto-pulmonary hypertension;
* Has hepato-pulmonary syndrome;
* Transplant procedure is a veno-venous bypass procedure;
* Is a living-donor transplant or a split liver transplant;
* Is scheduled to undergo liver transplant surgery with HCC exception points; or
* Has other unspecified reason/condition that, in the opinion of the clinical site PI, make the patient unsuitable for enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04531592
Study Brief:
Protocol Section:
NCT04531592