Clinical trial NCT05526326: OrganOx Metra® New Enrollment PAS
Official title: OrganOx Metra® New Enrollment Post-Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Keywords: Liver transplantation
Normothermic perfusion
Biliary complications
Lead sponsor: OrganOx Ltd.
Sponsor class: INDUSTRY
First posted: 2022-09-02
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult primary liver transplant candidates on the waiting list for liver transplant at a U.S. liver transplant center and who meet the eligibility criteria at the participating study centers

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse biliary-related events
timeFrame: 12-months post-transplant
Secondary outcomes:
measure: Graft survival
timeFrame: 12-months post-transplant
measure: Subject survival
timeFrame: 12-months post-transplant
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: St Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References: