US National OCS Liver Perfusion (OLP) Registry

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
TransMedics
Study ID
NCT05940857
Status
Recruiting
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Conditions

  • Liver Transplant

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 14, 2021
Status verified
Aug 2024
Primary completion
Oct 31, 2031
Completion
Oct 31, 2031

Study Design

Enrollment
100,000 participants (estimated)

Arms

  • Arm: 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.
  • Arm: Non-OCS Liver Transplant Recipients
    Patients transplanted using other preservation modalities for clinical outcomes.

Primary Outcome Measure

Survival [ Time Frame: 5 years post-transplant ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35294
Leigh McManus
Robert Cannon, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Hospital ArizonaPhoenixArizona85054
Dakota Hohenwalter
Amit K. Mathur, MD (PRINCIPAL_INVESTIGATOR)
University of California San DiegoLa JollaCalifornia92037
Denya Arellano
Gabriel Schnickel, MD, MPH (PRINCIPAL_INVESTIGATOR)
University of California San FranciscoSan FranciscoCalifornia94143
Joanne Kwan
Garrett Roll, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Hospital FloridaJacksonvilleFlorida32224
Jessica Toukmehji
Shennen Mao, MD (PRINCIPAL_INVESTIGATOR)
Emory University HospitalAtlantaGeorgia30322
Jeryl Huckaby
Denise Jennifer Lo, MD (PRINCIPAL_INVESTIGATOR)
University of Kentucky Medical CenterLexingtonKentucky40536
Deepa Valvi
Malay B Shah (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Madelyn Subocz
David D. Lee, MD (PRINCIPAL_INVESTIGATOR)
Lahey Clinic Medical CenterBurlingtonMassachusetts01805
Kirsten Peterson
Mohamed E. Akoad, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan Medical CenterAnn ArborMichigan48109
Nicholas Demchuk
Seth Waits, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford HospitalDetroitMichigan48202
Matthew Callaghan
Iman Francis
Ahmed Nassar, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Hospital MinnesotaRochesterMinnesota55905
Candy Peterman
Julie K. Heimbach, MD (PRINCIPAL_INVESTIGATOR)
SSM Health Saint Louis University HospitalSt LouisMissouri63103
Craig Dedert
Henry Randall, MD (PRINCIPAL_INVESTIGATOR)
University of Nebraska Medical CenterOmahaNebraska68198
Michelle Leahy
Shaheed Merani, MD, PhD (PRINCIPAL_INVESTIGATOR)
NY Presbyterian Hospital/Columbia Univ. Medical CenterNew YorkNew York10032
Rachel Nuccitelli
Tomoaki Kato, MD (PRINCIPAL_INVESTIGATOR)
Carolinas Medical Center/Atrium HealthCharlotteNorth Carolina28203
Katheryn Peterson
Dionisios Vrochides, MD, PhD (PRINCIPAL_INVESTIGATOR)
Duke Medical CenterDurhamNorth Carolina27710
Jerry Turner
Debra Sudan, MD (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Willa Meyer
Ashesh Shah, MD (PRINCIPAL_INVESTIGATOR)
UT Southwestern Medical CenterDallasTexas75390
Morgan Marsh
David Wojciechowski, DO (PRINCIPAL_INVESTIGATOR)
Houston MethodistHoustonTexas77030
Deborah Pokrass
Mark Hobeika, MD (PRINCIPAL_INVESTIGATOR)
University Hospital, University of Texas Health Science CenterSan AntonioTexas78229
Jillian Woodworth
Tarunjeet S Klair, MD (PRINCIPAL_INVESTIGATOR)
University of Utah Medical CenterSalt Lake CityUtah84112
Chinedu Nwaduru, MD
Motaz Selim, MD, PhD (PRINCIPAL_INVESTIGATOR)

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