OCS Liver Perfusion (OLP) Post-Approval Registry

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Liver Transplant
• Intervention / Treatment: Device: OCS Liver

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 Type: Observational
• Enrollment (Actual): 166

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
  • California
    • La Jolla, California, United States, 92037
      • University of California San Diego
    • San Francisco, California, United States, 94143
      • University of California San Francisco
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Potential participants in the OLP Registry will be all adult primary liver transplant candidates on the waiting list for liver transplant at a U.S. liver transplant center and who meet the eligibility criteria at the participating Registry centers.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OLP Registry primary analysis population; 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	Device: OCS Liver; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Survival	1-year patient survival with the originally transplanted liver (patient and graft survival) post-Liver transplant.	1 year post-Liver transplant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint	6-months liver graft survival post-Liver transplant	6 months post-Liver transplant
Long Term Patient Survival	K-M Patient survival at 1- and 2-years post-transplant	2 years post-transplant
Long Term Graft Survival	K-M Graft survival at 6 months, 1- and 2-years post-transplant	2 years post-transplant

Collaborators and Investigators

• Sponsor: TransMedics

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Actual): March 22, 2024
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: OCSLIVER-01-PAS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes