OCS Liver Perfusion (OLP) Post-Approval Registry

TransMedics

Status: Active, not recruiting

Conditions: Liver Transplant

Treatments: Device: OCS Liver

Study type: Observational

Funder types: Industry

Identifiers

NCT05074160

OCSLIVER-01-PAS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

166 participants in 1 patient group

OLP Registry primary analysis population

Description:

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

Treatment:

Device: OCS Liver