Liver Transplant
Conditions
Brief summary
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.
Detailed description
OLP Registry is a multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.
Interventions
DEVICEOCS Liver
Multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.
Sponsors
TransMedics
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Survival | 1 year post-Liver transplant | 1-year patient survival with the originally transplanted liver (patient and graft survival) post-Liver transplant. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint | 6 months post-Liver transplant | 6-months liver graft survival post-Liver transplant |
| Long Term Patient Survival | 2 years post-transplant | K-M Patient survival at 1- and 2-years post-transplant |
| Long Term Graft Survival | 2 years post-transplant | K-M Graft survival at 6 months, 1- and 2-years post-transplant |
Countries
United States
Outcome results
None listed