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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Other
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
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
    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.

More Details

Status
Active, not recruiting
Sponsor
TransMedics

Study Contact

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.