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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OLP Registry primary analysis population | Adult primary liver transplant recipients who are transplanted with an OCS perfused DBD or DCD donor liver according to the approved indication and matching eligibility criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCS Liver | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Survival | 1-year patient survival with the originally transplanted liver (patient and graft survival) post-Liver transplant. | 1 year post-Liver transplant |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint | 6-months liver graft survival post-Liver transplant | 6 months post-Liver transplant |
| Long Term Patient Survival | K-M Patient survival at 1- and 2-years post-transplant |
Inclusion Criteria:
Donor Exclusion Criteria:
Recipient Exclusion Criteria:
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Potential participants in the OLP Registry will be all adult primary liver transplant candidates on the waiting list for liver transplant at a U.S. liver transplant center and who meet the eligibility criteria at the participating Registry centers.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| University of California San Diego |
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| 2 years post-transplant |
| Long Term Graft Survival | K-M Graft survival at 6 months, 1- and 2-years post-transplant | 2 years post-transplant |
| La Jolla |
| California |
| 92037 |
| United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| Emory | Atlanta | Georgia | 30322 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Duke Medical Center | Durham | North Carolina | 27710 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |