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 @ 2:45 PM
Ignite Modification Date:
2025-12-24 @ 2:45 PM
NCT ID:
NCT03930459
Eligibility Criteria:
Inclusion Criteria:
LIVER DONOR:
* Donors older than 16 years
* Liver donation grafts due to brain death
* Steatosis confirmed by histological study (between 30% and 60% of macrovesicular steatosis)
LIVER RECIPIENT:
* Adult patients (18 years or older)
* Active liver transplant waiting list candidate
* Able to give informed consent
Exclusion Criteria:
LIVER DONOR:
* Living donors
* Liver destined to the transplant "split"
* Donor age \<16 years
* Donation after death due to asystole.
* When the biopsy establishes a steatosis ≥ 50%, patients who fulfill at least 3 of the following 5 risk factors will be excluded: Transaminases (AST and ALT) ≥ 200 U / L; Age ≥ 55 years; Hypernatremia ≥ 155 mEq / L; Cardiovascular risk factors, at least 2 of the following 5: DM, HTA, IMC ≥ 35, Active smoking, ischemic stroke; Days of stay in ICU ≥ 4 days with vasoactive drugs (noradrenaline or dobutamine at any dose)
LIVER RECIPIENT:
* Age under 18
* Acute/fulminant hepatic failure
* Transplant of more than one organ (for example, liver and kidney)
* Rejection of informed consent
* Unable to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03930459
Study Brief:
Protocol Section:
NCT03930459