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

August 13, 2024 updated by: TransMedics

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of the sponsor-initiated OLP-II Registry is to collect data on the post-transplant clinical outcomes of donor livers preserved and assessed on OCS Liver System and to document performance of the OCS device in the realworld setting.

Study Type

Observational

Enrollment (Estimated)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University Of Alabama
        • Contact:
          • Leigh McManus
        • Principal Investigator:
          • Robert Cannon, MD
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Hospital Arizona
        • Principal Investigator:
          • Amit K. Mathur, MD
        • Contact:
          • Dakota Hohenwalter
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California San Diego
        • Principal Investigator:
          • Gabriel Schnickel, MD, MPH
        • Contact:
          • Denya Arellano
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco
        • Principal Investigator:
          • Garrett Roll, MD
        • Contact:
          • Joanne Kwan
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Hospital Florida
        • Principal Investigator:
          • Shennen Mao, MD
        • Contact:
          • Jessica Toukmehji
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Contact:
          • Jeryl Huckaby
        • Principal Investigator:
          • Denise Jennifer Lo, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky Medical Center
        • Contact:
          • Deepa Valvi
        • Principal Investigator:
          • Malay B Shah
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
          • Madelyn Subocz
        • Principal Investigator:
          • David D. Lee, MD
      • Burlington, Massachusetts, United States, 01805
        • Recruiting
        • Lahey Clinic Medical Center
        • Contact:
          • Kirsten Peterson
        • Principal Investigator:
          • Mohamed E. Akoad, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Medical Center
        • Contact:
          • Nicholas Demchuk
        • Principal Investigator:
          • Seth Waits, MD
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
          • Iman Francis
        • Principal Investigator:
          • Ahmed Nassar, MD
        • Contact:
          • Matthew Callaghan
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Hospital Minnesota
        • Contact:
          • Candy Peterman
        • Principal Investigator:
          • Julie K. Heimbach, MD
    • Missouri
      • Saint Louis, Missouri, United States, 63103
        • Recruiting
        • SSM Health Saint Louis University Hospital
        • Principal Investigator:
          • Henry Randall, MD
        • Contact:
          • Craig Dedert
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Principal Investigator:
          • Shaheed Merani, MD, PhD
        • Contact:
          • Michelle Leahy
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • NY Presbyterian Hospital/Columbia Univ. Medical Center
        • Principal Investigator:
          • Tomoaki Kato, MD
        • Contact:
          • Rachel Nuccitelli
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center/Atrium Health
        • Contact:
          • Katheryn Peterson
        • Principal Investigator:
          • Dionisios Vrochides, MD, PhD
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Medical Center
        • Principal Investigator:
          • Debra Sudan, MD
        • Contact:
          • Jerry Turner
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Contact:
          • Willa Meyer
        • Principal Investigator:
          • Ashesh Shah, MD
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
        • Principal Investigator:
          • David Wojciechowski, DO
        • Contact:
          • Morgan Marsh
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist
        • Contact:
          • Deborah Pokrass
        • Principal Investigator:
          • Mark Hobeika, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University Hospital, University of Texas Health Science Center
        • Contact:
          • Jillian Woodworth
        • Principal Investigator:
          • Tarunjeet S Klair, MD
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah Medical Center
        • Contact:
          • Chinedu Nwaduru, MD
        • Principal Investigator:
          • Motaz Selim, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

All liver transplant recipients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: OCS Liver
The TransMedics® Organ Care System (OCS) Liver is an FDA approved portable extracorporeal liver perfusion and monitoring system.
Non-OCS Liver Transplant Recipients
Patients transplanted using other preservation modalities for clinical outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TransMedics

Investigators

  • Study Director: Ahmed Elbetanony, MD, TransMedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2021

Primary Completion (Estimated)

October 1, 2031

Study Completion (Estimated)

October 1, 2031

Study Registration Dates

First Submitted

June 29, 2023

First Submitted That Met QC Criteria

July 10, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • OCS-LIVER-OLP-II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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