OCS Liver Perfusion (OLP) Post-Approval Registry
Running, not enrolling
Conditions studied: Liver Transplant
In brief
The objective of the OLP Registry is to collect more data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on OCS Liver System according to the approved indication and the OCS device performance in the real-world setting.
Key facts
- Study ID
- NCT05074160
- Run by
- TransMedics
- People needed
- 166
- Starts
- 2021-10-14
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2025-04-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
Where it is running
- University of Alabama — Birmingham, Alabama, United States
- University of California San Diego — La Jolla, California, United States
- University of California San Francisco — San Francisco, California, United States
- Emory — Atlanta, Georgia, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Duke Medical Center — Durham, North Carolina, United States
- Houston Methodist — Houston, Texas, United States
Full record on ClinicalTrials.gov
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