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:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT01274520
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed IRB consent by patient or patient's legally appointed representative.
* Be at least 18 years of age; male or female.
* Listed with UNOS for liver transplantation.
* Organ declined by at least one transplant center
* Extended criteria donor as defined by:
* Presence of hepatitis C antibody
* Donation after Cardiac Death (DCD)
* Severe Hypernatremia: donor serum sodium \>165 meq/L for at least 12 hours prior to procurement
* Donor age ≥65 years
* Presence of significant steatosis \>25% macrovesicular by biopsy
* Evidence of significant donor ischemic injury
* Current donor serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1000 IU/L
* Ischemic injury evidenced by prolonged hypotension, high pressor requirement and/or rising serum liver function tests or one test more than five times the upper limit of normal (AST, ALT, or Total Bilirubin)
Exclusion Criteria:
* Patients in whom the donor liver will be subjected to less than 4 hours of cold ischemia (surgeon desires immediate implantation)
* Patient hospitalized in intensive care unit (ICU) at time of transplantation and/or physiologic MELD score \>35
* Dual organ recipient
* ABO incompatibility
* Retransplantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01274520
Study Brief:
Protocol Section:
NCT01274520