NCT02478151

Brief Summary

This trial will examine the safety and feasibility of using the OrganOx Metra device to transport and store donor livers under normothermic conditions prior to transplantation. Participants will be followed for 3 months following transplantation and their outcomes recorded.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

7.4 years

First QC Date

December 1, 2014

Last Update Submit

April 8, 2022

Conditions

End-stage Liver Disease

Keywords

Deceased donor liver transplantNormothermic machine perfusion

Outcome Measures

Primary Outcomes (3)

  • Rates of primary graft non-function

    3 months

  • Rates of re-transplantation

    3 months

  • Rates of recipient death

    3 months

Secondary Outcomes (11)

  • Rate of device failures resulting in organ discard

    3 months

  • Recruitment rates to the study

    3 months

  • Ischemia- reperfusion injury associated with organ storage

    7 days

  • Ischemia- reperfusion injury associated with organ storage

    7 days

  • The function of liver grafts stored with the Metra™ device

    3 months

  • +6 more secondary outcomes

Study Arms (1)

OrganOx Metra

EXPERIMENTAL

OrganOx Metra Device

Device: OrganOx Metra

Interventions

OrganOx MetraDEVICE

Normothermic machine perfusion (NMP) Metra device

OrganOx Metra

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (18 years or more)
  • Active on the waiting list for liver transplantation
  • Able to give informed consent

You may not qualify if:

  • Age less than 18 years
  • Acute/fulminant liver failure
  • Transplantation of more than one organ (e.g. liver and kidney)
  • Refusal of informed consent
  • Unable to give informed consent
  • Re-transplantation Diagnosis of Hepatopulmonary Syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • David R Grant, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2014

First Posted

June 23, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2022

Study Completion

March 31, 2023

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations

CA(1)