OCS Liver Perfusion (OLP) Post-Approval Registry

NCT05074160 | Active Not Recruiting FDA Device

• 1 other identifier: OCSLIVER-01-PAS
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 9

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.

Conditions

Liver Transplant

Outcome Measures

Primary Outcomes (1)

• Patient Survival

  1-year patient survival with the originally transplanted liver (patient and graft survival) post-Liver transplant.

  1 year post-Liver transplant

Other Outcomes (3)

• Safety Endpoint

  6 months post-Liver transplant

• Long Term Patient Survival

  2 years post-transplant

• Long Term Graft Survival

  2 years post-transplant

Study Arms (1)

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

Interventions

OCS Liver DEVICE

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.

OLP Registry primary analysis population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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%
• 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.

Sponsors & Collaborators

• TransMedics: lead

Study Sites (9)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Emory

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Duke Medical Center

Durham, North Carolina, 27710, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: October 14, 2021
• Primary Completion: March 22, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

US (9)