Recruiting

Observational StudyUS National OCS Liver Perfusion (OLP) Registry

Sponsor:

TransMedics

Code:

NCT05940857

Conditions

Liver Transplant

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

OCS Liver

Study Details

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.

Conditions

Liver Transplant

Study ID

NCT05940857

Start date

Oct 14, 2021

Status verified date

Aug, 2024

Completion date

Oct, 2031

Anticipated

Primary completion date

Oct, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

All liver transplant recipients.

Study Design

Enrollment

100000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

OCS Liver

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

Primary outcome measure

Survival [ Time Frame: 5 years post-transplant ]

Central Contacts and Locations

Central contacts

Kelly Jork

978-494-3918 kjork@transmedics.com

Kausar Qidwai

kqidwai@transmedics.com

Locations

University of Alabama

Recruiting

Birmingham, Alabama, United States, 35294

Principal Investigator:

Robert Cannon, MD

Mayo Clinic Hospital Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Principal Investigator:

Amit K. Mathur, MD

University of California San Diego

Recruiting

La Jolla, California, United States, 92037

Principal Investigator:

Gabriel Schnickel, MD, MPH

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Principal Investigator:

Garrett Roll, MD

Mayo Clinic Hospital Florida

Recruiting

Jacksonville, Florida, United States, 32224

Principal Investigator:

Shennen Mao, MD

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator:

Denise Jennifer Lo, MD

University of Kentucky Medical Center

Recruiting

Lexington, Kentucky, United States, 40536

Principal Investigator:

Malay B Shah

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

David D. Lee, MD

Lahey Clinic Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805

Principal Investigator:

Mohamed E. Akoad, MD

University of Michigan Medical Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator:

Seth Waits, MD

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Principal Investigator:

Ahmed Nassar, MD

Mayo Clinic Hospital Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Julie K. Heimbach, MD

SSM Health Saint Louis University Hospital

Recruiting

Saint Louis, Missouri, United States, 63103

Principal Investigator:

Henry Randall, MD

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Principal Investigator:

Shaheed Merani, MD, PhD

NY Presbyterian Hospital/Columbia Univ. Medical Center

Recruiting

New York, New York, United States, 10032

Principal Investigator:

Tomoaki Kato, MD

Carolinas Medical Center/Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28203

Principal Investigator:

Dionisios Vrochides, MD, PhD

Duke Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator:

Debra Sudan, MD

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Principal Investigator:

Ashesh Shah, MD

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Principal Investigator:

David Wojciechowski, DO

Houston Methodist

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Mark Hobeika, MD

University Hospital, University of Texas Health Science Center

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Tarunjeet S Klair, MD

University of Utah Medical Center

Recruiting

Salt Lake City, Utah, United States, 84112

Principal Investigator:

Motaz Selim, MD, PhD

More Information

Sponsor

TransMedics

Last update posted

Aug 16, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by TransMedics on 2024-08-16.