US National OCS Liver Perfusion (OLP) Registry

NCT ID: NCT05940857

Last Updated: 2024-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-14

Study Completion Date

2031-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Transplant

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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.

OCS Liver

Intervention Type DEVICE

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.

No interventions assigned to this group

Interventions

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OCS Liver

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

All liver transplant recipients.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TransMedics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmed Elbetanony, MD

Role: STUDY_DIRECTOR

TransMedics

Locations

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University of Alabama

Birmingham, Alabama, United States

Site Status RECRUITING

Mayo Clinic Hospital Arizona

Phoenix, Arizona, United States

Site Status RECRUITING

University of California San Diego

La Jolla, California, United States

Site Status RECRUITING

University of California San Francisco

San Francisco, California, United States

Site Status RECRUITING

Mayo Clinic Hospital Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Emory University Hospital

Atlanta, Georgia, United States

Site Status RECRUITING

University of Kentucky Medical Center

Lexington, Kentucky, United States

Site Status RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Lahey Clinic Medical Center

Burlington, Massachusetts, United States

Site Status RECRUITING

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Site Status RECRUITING

Henry Ford Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Mayo Clinic Hospital Minnesota

Rochester, Minnesota, United States

Site Status RECRUITING

SSM Health Saint Louis University Hospital

St Louis, Missouri, United States

Site Status RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

NY Presbyterian Hospital/Columbia Univ. Medical Center

New York, New York, United States

Site Status RECRUITING

Carolinas Medical Center/Atrium Health

Charlotte, North Carolina, United States

Site Status RECRUITING

Duke Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Houston Methodist

Houston, Texas, United States

Site Status RECRUITING

University Hospital, University of Texas Health Science Center

San Antonio, Texas, United States

Site Status RECRUITING

University of Utah Medical Center

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kelly Jork

Role: CONTACT

978-494-3918

Kausar Qidwai

Role: CONTACT

Facility Contacts

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Leigh McManus

Role: primary

Dakota Hohenwalter

Role: primary

Denya Arellano

Role: primary

Joanne Kwan

Role: primary

Jessica Toukmehji

Role: primary

Jeryl Huckaby

Role: primary

Deepa Valvi

Role: primary

Madelyn Subocz

Role: primary

Kirsten Peterson

Role: primary

Nicholas Demchuk

Role: primary

Matthew Callaghan

Role: primary

Iman Francis

Role: backup

Candy Peterman

Role: primary

Craig Dedert

Role: primary

Michelle Leahy

Role: primary

Rachel Nuccitelli

Role: primary

Katheryn Peterson

Role: primary

Jerry Turner

Role: primary

Willa Meyer

Role: primary

Morgan Marsh

Role: primary

Deborah Pokrass

Role: primary

Jillian Woodworth

Role: primary

Chinedu Nwaduru, MD

Role: primary

Other Identifiers

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OCS-LIVER-OLP-II

Identifier Type: -

Identifier Source: org_study_id

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