NCT05526326

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 10, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

2.2 years

First QC Date

August 30, 2022

Last Update Submit

March 30, 2025

Conditions

Liver Transplantation

Keywords

Liver transplantationNormothermic perfusionBiliary complications

Outcome Measures

Primary Outcomes (1)

  • Adverse biliary-related events

    Adverse biliary-related events as measured by biliary complications

    12-months post-transplant

Secondary Outcomes (2)

  • Graft survival

    12-months post-transplant

  • Subject survival

    12-months post-transplant

Study Arms (1)

Post-Approval Transplant Recipient cohort

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

Interventions

Transplant with normothermic machine perfused (NMP) donor liverDEVICE

The enrolled recipient will receive a DBD or DCD donor liver that underwent normothermic machine perfusion with the OrganOx metra®

Also known as: OrganOx metra® normothermic machine perfusion
Post-Approval Transplant Recipient cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Loyola University

Maywood, Illinois, 60153, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

Transplantation

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 2, 2022

Study Start

November 10, 2022

Primary Completion

February 5, 2025

Study Completion

February 5, 2025

Last Updated

April 3, 2025

Record last verified: 2025-03

Locations

US(10)