US National OCS Liver Perfusion (OLP) Registry
ConditionLiver Transplant
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorTransMedics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
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.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
OCS Liver
DeviceThe TransMedics® Organ Care System (OCS) Liver is an FDA approved portable extracorporeal liver perfusion and monitoring system.
Treatment groups
100,000 Participants
are divided into 2 treatment groupsGroup A: OCS Liver Transplant Recipients1 intervention
Group B: Non-OCS Liver Transplant Recipients0 interventions
Trial outcomes
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.
Time frame
5 years post-transplantSponsors and contacts
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Source ClinicalTrials.gov