OrganOx metra for End Stage Liver Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
End Stage Liver Disease+1 MoreOrganOx metra - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is to assess the safety and efficacy of normothermic machine perfusion as an organ preservation method prior to transplantation.

Eligible Conditions
  • End Stage Liver Disease
  • Liver Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Day 30

Day 0
Perfusate AST levels
Perfusate alanine transaminase (ALT) levels
Perfusate bilirubin levels
Perfusate lactate levels
Day 30
Graft survival rate
Patient survival rate
Up to Day 7
Daily lactate levels
Early Allograft Dysfunction (EAD) rate
Peak aspartate transaminase (AST) levels

Trial Safety

Trial Design

1 Treatment Group

Normothermic Machine Perfusion (OrganOx metra)
1 of 1

Experimental Treatment

150 Total Participants · 1 Treatment Group

Primary Treatment: OrganOx metra · No Placebo Group · Phase 1 & 2

Normothermic Machine Perfusion (OrganOx metra)
Device
Experimental Group · 1 Intervention: OrganOx metra · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OrganOx metra
2016
N/A
~30

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 30

Who is running the clinical trial?

University of AlbertaLead Sponsor
815 Previous Clinical Trials
376,674 Total Patients Enrolled
James Shapiro, MD, PhDPrincipal InvestigatorUniversity of Alberta
8 Previous Clinical Trials
181 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Grafts that meet the following criteria may be transplanted, at the discretion of the transplant surgeon: they must be safe and appropriate for the individual recipient.
The expanded criteria for donation after neurological determination of death (NDD) may include livers that have ≥60% macro/micro steatosis, cold ischemia time of > 10 hours, combined steatosis of 30-60% and >6hr cold storage, and significant liver trauma.
A graft that is evenly perfused will have a more consistent blood flow and will be less likely to fail.
The pH of the perfusate was stable within the normal range after bicarbonate correction.
People who are at least 18 years old and are on the waiting list for a liver transplant at the University of Alberta Hospital can either choose to take part in the study or decline
The text discusses the donation of livers from deceased donors
Donor livers will be placed on the metra™ device either at the donor hospital, or transported to the University of Alberta hospital
The portal vein flow is normal and the artery flow is stable.
The new expanded criteria for livers donated after cardio-circulatory death (DCD) may include livers from people aged up to 75, with mild steatosis (30%), and offers from distant centres