US National OCS Liver Perfusion (OLP) Registry

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.

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Key information

Conditions

Liver Transplant

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

All liver transplant recipients.

Treatment and study plan

OCS Liver

Device

The TransMedics® Organ Care System (OCS) Liver is an FDA approved portable extracorporeal liver perfusion and monitoring system.

Primary outcomes

Survival

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kausar Qidwai

CONTACT

[email protected]

Kelly Jork

CONTACT

[email protected]

978-494-3918

Sponsors and collaborators

Lead sponsor

TransMedics

Industry

Registry information

Acronym: National OLP

Important dates

Study start: 2021
Primary completion: 2031
Study completion: 2031
First posted: Jul 11, 2023
Registry last updated: Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting