US National OCS Liver Perfusion (OLP) Registry
- Conditions
- Liver Transplant
- Interventions
- Device: OCS Liver
- Registration Number
- NCT05940857
- Lead Sponsor
- TransMedics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description OCS Liver Transplant Recipients OCS Liver The US National OLP Registry will enroll all liver transplant recipients who are transplanted with an OCS-perfused donor liver in the Registry.
- Primary Outcome Measures
Name Time Method Survival 5 years post-transplant 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
NY Presbyterian Hospital/Columbia Univ. Medical Center
🇺🇸New York, New York, United States
Mayo Clinic Hospital Florida
🇺🇸Jacksonville, Florida, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Houston Methodist
🇺🇸Houston, Texas, United States
Duke Medical Center
🇺🇸Durham, North Carolina, United States
University Hospital, University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States
University of Utah Medical Center
🇺🇸Salt Lake City, Utah, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Lahey Clinic Medical Center
🇺🇸Burlington, Massachusetts, United States
Carolinas Medical Center/Atrium Health
🇺🇸Charlotte, North Carolina, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
SSM Health Saint Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Mayo Clinic Hospital Arizona
🇺🇸Phoenix, Arizona, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic Hospital Minnesota
🇺🇸Rochester, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States