US National OCS Liver Perfusion (OLP) Registry
National OLP
1 other identifier
observational
100,000
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Longer than P75 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 14, 2021
CompletedFirst Submitted
Initial submission to the registry
June 29, 2023
CompletedFirst Posted
Study publicly available on registry
July 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2031
August 16, 2024
August 1, 2024
10 years
June 29, 2023
August 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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.
Interventions
The TransMedics® Organ Care System (OCS) Liver is an FDA approved portable extracorporeal liver perfusion and monitoring system.
Eligibility Criteria
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.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- TransMedicslead
Study Sites (22)
University of Alabama
Birmingham, Alabama, 35294, United States
Mayo Clinic Hospital Arizona
Phoenix, Arizona, 85054, United States
University of California San Diego
La Jolla, California, 92037, United States
University of California San Francisco
San Francisco, California, 94143, United States
Mayo Clinic Hospital Florida
Jacksonville, Florida, 32224, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Mayo Clinic Hospital Minnesota
Rochester, Minnesota, 55905, United States
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63103, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
NY Presbyterian Hospital/Columbia Univ. Medical Center
New York, New York, 10032, United States
Carolinas Medical Center/Atrium Health
Charlotte, North Carolina, 28203, United States
Duke Medical Center
Durham, North Carolina, 27710, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Houston Methodist
Houston, Texas, 77030, United States
University Hospital, University of Texas Health Science Center
San Antonio, Texas, 78229, United States
University of Utah Medical Center
Salt Lake City, Utah, 84112, United States
Study Officials
- STUDY DIRECTOR
Ahmed Elbetanony, MD
TransMedics
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2023
First Posted
July 11, 2023
Study Start
October 14, 2021
Primary Completion (Estimated)
October 1, 2031
Study Completion (Estimated)
October 1, 2031
Last Updated
August 16, 2024
Record last verified: 2024-08