OCS Liver Perfusion (OLP) Post-Approval Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-14

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Liver Transplant

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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

OCS Liver

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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%

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No