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.
Study Type
OBSERVATIONAL
Enrollment
100,000
The TransMedics® Organ Care System (OCS) Liver is an FDA approved portable extracorporeal liver perfusion and monitoring system.
University of Alabama
Birmingham, Alabama, United States
RECRUITINGMayo Clinic Hospital Arizona
Phoenix, Arizona, United States
RECRUITINGUniversity of California San Diego
La Jolla, California, United States
RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGMayo Clinic Hospital Florida
Jacksonville, Florida, United States
RECRUITINGEmory University Hospital
Atlanta, Georgia, United States
RECRUITINGUniversity of Kentucky Medical Center
Lexington, Kentucky, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGLahey Clinic Medical Center
Burlington, Massachusetts, United States
RECRUITINGUniversity of Michigan Medical Center
Ann Arbor, Michigan, United States
RECRUITING...and 12 more locations
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.
Time frame: 5 years post-transplant
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