OrganOx Metra® New Enrollment PAS

Study Overview
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Brief Summary
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The objective of the OrganOx metra® New Enrollment Post-Approval Study is to collect data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on the OrganOx according to the current indications for use in the real-world setting.

Detailed Description
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The OrganOx metra® New Enrollment Post-Approval Study is a multi-site, single arm, unblinded post-approval study that will enroll deceased DBD or DCD donor liver and adult liver transplant recipients according to the current indication and that match the eligibility criteria below.

Official Title
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OrganOx Metra® New Enrollment Post-Approval Study

Conditions
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Liver Transplantation

Intervention / Treatment
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* Device: Transplant with normothermic machine perfused (NMP) donor liver


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 years of age or greater Subject is registered as an active recipient on the UNOS waiting list for liver transplantation Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization Subject is able and willing to comply with all study requirements (in the opinion of the Investigator) Exclusion Criteria: Subject requiring all of the following at the time of transplantation: Oxygen therapy via a ventilator/respirator Inotropic support Renal replacement therapy Subject has acute/fulminant liver failure (UNOS status 1A) Subject planned to undergo simultaneous transplantation of more than one organ (e.g., liver and kidney) from the same liver donor Subject is pregnant (as confirmed by urine or serum pregnancy test) or nursing Concurrent enrollment in another clinical study. Subjects enrolled in clinical studies or registries where only measurements and/or samples are taken (no test device or test drug) are allowed to participate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-Approval Transplant Recipient cohort<br>Adult liver transplant recipients who are transplanted with an OrganOx metra® perfused DBD or DCD donor liver according to the approved indication and matching eligibility criteria | Device: Transplant with normothermic machine perfused (NMP) donor liver<br>* The enrolled recipient will receive a DBD or DCD donor liver that underwent normothermic machine perfusion with the OrganOx metra®<br>* Other names: OrganOx metra® normothermic machine perfusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse biliary-related events | Adverse biliary-related events as measured by biliary complications | 12-months post-transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft survival | Liver graft survival post-liver transplant as measured by the number of subjects needing a re-transplant | 12-months post-transplant | 
| Subject survival | Subject survival post-liver transplant | 12-months post-transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver transplantation, Normothermic perfusion, Biliary complications