OCS Liver Perfusion (OLP) Post-Approval Registry

Active, not recruiting

• Conditions: Liver Transplant
• Interventions: Device: OCS Liver

• 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

Arm && Interventions

Group	Intervention	Description
OLP Registry primary analysis population	OCS Liver	Adult primary liver transplant recipients who are transplanted with an OCS perfused DBD or DCD donor liver according to the approved indication and matching eligibility criteria

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 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

Houston Methodist; 🇺🇸 Houston, Texas, United States

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

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

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

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