OCS Liver Perfusion (OLP) Post-Approval Registry

N/AActive Not RecruitingNCT05074160

TransMedics166 enrolled

Overview

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.

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

166

Conditions

Liver Transplant

Interventions

OCS LiverDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

Patient Survival

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

Time frame: 1 year post-Liver transplant

Data from ClinicalTrials.gov

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