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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT05074160
Eligibility Criteria:
Inclusion Criteria:
* Adult primary liver transplant recipients of DBD or DCD donor Livers perfused on OCS Liver System
Donor Exclusion Criteria:
* Donor livers with accessory arterial blood supply requiring back table anastomosis, major traumatic injury, or hematoma; or
* Split donor liver; or
* DCD donor liver with \>30 minutes of warm ischemic time (defined as from withdrawal of life support until donor liver cold flush); or
* DCD donors age \>55 years; or
* DCD donor liver with macrosteatosis of \>15%
* Living donors
* Donors with positive serology for HIV, Hep B and C
* Donors with macrosteatosis of ≥40%
Recipient Exclusion Criteria:
* Fulminant liver failure; or
* Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
* Chronic renal dialysis at time of transplant; or
* Dependency on more than 1 inotropic agent to maintain hemodynamics; or
* Ventilator dependent at time of transplant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05074160
Study Brief:
Protocol Section:
NCT05074160