Liver Transplantation
Conditions
Keywords
Liver transplantation, Normothermic perfusion, Biliary complications
Brief summary
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
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.
Interventions
DEVICETransplant with normothermic machine perfused (NMP) donor liver
The enrolled recipient will receive a DBD or DCD donor liver that underwent normothermic machine perfusion with the OrganOx metra®
Sponsors
OrganOx Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Oxygen therapy via a ventilator/respirator 2. Inotropic support 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse biliary-related events | 12-months post-transplant | Adverse biliary-related events as measured by biliary complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft survival | 12-months post-transplant | Liver graft survival post-liver transplant as measured by the number of subjects needing a re-transplant |
| Subject survival | 12-months post-transplant | Subject survival post-liver transplant |
Countries
United States
Outcome results
None listed