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OpenTrials
Active, Not Recruiting

NCT Number: NCT05074160

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Liver Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Patient Survival

    Time frame: 1 year post-Liver transplant

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

Other outcomes

  1. Safety Endpoint

    Time frame: 6 months post-Liver transplant

    6-months liver graft survival post-Liver transplant

  2. Long Term Patient Survival

    Time frame: 2 years post-transplant

    K-M Patient survival at 1- and 2-years post-transplant

  3. Long Term Graft Survival

    Time frame: 2 years post-transplant

    K-M Graft survival at 6 months, 1- and 2-years post-transplant

Sponsors and collaborators

Lead sponsor

TransMedics

Industry

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Oct 12, 2021
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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