US National OCS Liver Perfusion (OLP) Registry

Recruiting

• Conditions: Liver Transplant

• Registration Number: NCT05940857
• Lead Sponsor: TransMedics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-14
• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-07-10
• Study First Posted: 2023-07-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-16
• Primary Completion: 2031-10
• Study Completion: 2031-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	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.

Trial Locations

Locations (22)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic Hospital Arizona; 🇺🇸 Phoenix, Arizona, United States

University of California San Diego; 🇺🇸 La Jolla, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Mayo Clinic Hospital Florida; 🇺🇸 Jacksonville, Florida, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

University of Kentucky Medical Center; 🇺🇸 Lexington, Kentucky, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Lahey Clinic Medical Center; 🇺🇸 Burlington, Massachusetts, United States

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States

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