US National OCS Liver Perfusion (OLP) Registry (National OLP)

TransMedics

Status: Enrolling

Conditions: Liver Transplant

Treatments: Device: OCS Liver

Study type: Observational

Funder types: Industry

Identifiers

NCT05940857

OCS-LIVER-OLP-II

Details and patient eligibility

About

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.

Enrollment: 100,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

All liver transplant recipients.

Trial design

100,000 participants in 2 patient groups

OCS Liver Transplant Recipients

Description:

The US National OLP Registry will enroll all liver transplant recipients who are transplanted with an OCS-perfused donor liver in the Registry.

Treatment:

Device: OCS Liver

Non-OCS Liver Transplant Recipients

Description:

Patients transplanted using other preservation modalities for clinical outcomes.