OCS Liver Perfusion (OLP) Post-Approval Registry

Active, not recruiting

• Conditions: Liver Transplant

• Registration Number: NCT05074160
• Lead Sponsor: TransMedics

Brief Summary

The objective of the OLP Registry is to collect more data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on OCS Liver System according to the approved indication and the OCS device performance in the real-world setting.

Detailed Description

OLP Registry is a multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.

Study Timeline

• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2021-09-29
• Study First Posted: 2021-10-12
• Study Start: 2021-10-14
• Primary Completion: 2024-03-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

• Adult primary liver transplant recipients of DBD or DCD donor Livers perfused on OCS Liver System

Donor

Exclusion Criteria

• Donor livers with accessory arterial blood supply requiring back table anastomosis, major traumatic injury, or hematoma; or
• Split donor liver; or
• DCD donor liver with >30 minutes of warm ischemic time (defined as from withdrawal of life support until donor liver cold flush); or
• DCD donors age >55 years; or
• DCD donor liver with macrosteatosis of >15%
• Living donors
• Donors with positive serology for HIV, Hep B and C
• Donors with macrosteatosis of ≥40%

Recipient Exclusion Criteria:

• Fulminant liver failure; or
• Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
• Chronic renal dialysis at time of transplant; or
• Dependency on more than 1 inotropic agent to maintain hemodynamics; or
• Ventilator dependent at time of transplant.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Survival	1 year post-Liver transplant	1-year patient survival with the originally transplanted liver (patient and graft survival) post-Liver transplant.

Trial Locations

Locations (9)

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

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

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

Emory; 🇺🇸 Atlanta, Georgia, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Duke Medical Center; 🇺🇸 Durham, North Carolina, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States