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This Registry is a sponsor-initiated, multi-center, observational, post-approval registry with an independent academic oversight.
TransMedics has contracted with United Network for Organ Sharing (UNOS) the Federal manager of the U.S. national transplant outcomes registry to obtain data that is routinely collected by the Organ Procurement and Transplantation Network (OPTN) on all transplanted organs in the U.S. for both the OCS liver transplanted patients as well as patients transplanted using other preservation modalities. Additional data will be collected by participating centers using OCS Liver perfusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCS Liver Transplant Recipients | The US National OLP Registry will enroll all liver transplant recipients who are transplanted with an OCS-perfused donor liver in the Registry. |
| |
| Non-OCS Liver Transplant Recipients | Patients transplanted using other preservation modalities for clinical outcomes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCS Liver | Device | The TransMedics® Organ Care System (OCS) Liver is an FDA approved portable extracorporeal liver perfusion and monitoring system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Recipients' patient and graft survival rates will be the primary clinical outcomes measures for all OCS Liver transplanted recipients compared to recipients receiving liver transplants using non-OCS preservation methods (cold static storage or other perfusion devices or a combination of both). This data will be obtained directly from UNOS/OPTN database. | 5 years post-transplant |
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All liver transplant recipients.
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All liver transplant recipients who are transplanted with an OCS-perfused donor liver will be enrolled in the Registry. Patients' clinical outcomes will be followed until the later of 5 years post-transplant, loss to follow-up or death.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelly Jork | Contact | 978-494-3918 | kjork@transmedics.com | |
| Kausar Qidwai | Contact | kqidwai@transmedics.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Elbetanony, MD | TransMedics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Recruiting | Birmingham | Alabama | 35294 | United States |
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| Mayo Clinic Hospital Arizona | Recruiting | Phoenix | Arizona | 85054 | United States |
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| University of California San Diego | Recruiting | La Jolla | California | 92037 | United States |
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| University of California San Francisco | Recruiting | San Francisco | California | 94143 | United States |
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| Mayo Clinic Hospital Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
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| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
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| University of Kentucky Medical Center | Recruiting | Lexington | Kentucky | 40536 | United States |
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| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Lahey Clinic Medical Center | Recruiting | Burlington | Massachusetts | 01805 | United States |
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| University of Michigan Medical Center | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Henry Ford Hospital | Recruiting | Detroit | Michigan | 48202 | United States |
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| Mayo Clinic Hospital Minnesota | Recruiting | Rochester | Minnesota | 55905 | United States |
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| SSM Health Saint Louis University Hospital | Recruiting | St Louis | Missouri | 63103 | United States |
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| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
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| NY Presbyterian Hospital/Columbia Univ. Medical Center | Recruiting | New York | New York | 10032 | United States |
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| Carolinas Medical Center/Atrium Health | Recruiting | Charlotte | North Carolina | 28203 | United States |
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| Duke Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| Thomas Jefferson University Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| Houston Methodist | Recruiting | Houston | Texas | 77030 | United States |
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| University Hospital, University of Texas Health Science Center | Recruiting | San Antonio | Texas | 78229 | United States |
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| University of Utah Medical Center | Recruiting | Salt Lake City | Utah | 84112 | United States |
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