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Organ Preservation Device
Normothermic Machine Perfusion for Liver Transplant
Phase 1 & 2
Waitlist Available
Led By James Shapiro, MD, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recipient inclusion criteria: Adult subjects (age ≥18 years) active on the waiting list for liver transplantation at the University of Alberta Hospital with informed/deferred consent provided
Donor livers will be placed on the metra™ device either at the donor hospital or transported to the University of Alberta hospital with ≤ 6 hours of cold storage and then reperfused on metra™ for ≥ 4 hours ('back-to-base' sub-analysis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30
Awards & highlights
Study Summary
This trial is to assess the safety and efficacy of normothermic machine perfusion as an organ preservation method prior to transplantation.
Who is the study for?
This trial is for adults on the liver transplant waiting list at the University of Alberta Hospital. It includes deceased donor livers up to age 75, with mild steatosis or from distant centers. Livers must weigh ≥40kg and be suitable for transplantation. Recipients cannot be minors, allergic to perfusion solution components, or without informed consent.Check my eligibility
What is being tested?
The safety and effectiveness of keeping a donated liver in near-normal conditions using OrganOx metra™ before it's transplanted are being tested. This method aims to preserve the organ better than traditional cold storage.See study design
What are the potential side effects?
Potential side effects aren't specified but may relate to how well the liver functions after transplant if preserved by this new method compared to standard practices.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult on the University of Alberta Hospital's liver transplant waiting list and have given consent.
Select...
My donor liver will be used with the metra™ device within 6 hours of being stored cold and then reperfused for over 4 hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Graft survival rate
Secondary outcome measures
Daily lactate levels
Early Allograft Dysfunction (EAD) rate
Patient survival rate
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Normothermic Machine Perfusion (OrganOx metra)Experimental Treatment1 Intervention
Donor livers will be placed on the OrganOx metra device for normothermic perfusion before transplantation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OrganOx metra
2016
N/A
~30
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
886 Previous Clinical Trials
384,672 Total Patients Enrolled
James Shapiro, MD, PhDPrincipal InvestigatorUniversity of Alberta
8 Previous Clinical Trials
181 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 or older, not allergic to the perfusion solution, and agree to give informed consent.My transplant surgeon will decide if the donated organ is right for me, considering its health and function.I am an adult on the University of Alberta Hospital's liver transplant waiting list and have given consent.The donor liver is from someone over 40kg and deemed suitable for transplant.My donor liver will be used with the metra™ device within 6 hours of being stored cold and then reperfused for over 4 hours.My liver transplant will not use a liver from a living donor.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Normothermic Machine Perfusion (OrganOx metra)
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants has the trial accepted thus far?
"Affirmative. Data recorded on clinicaltrials.gov shows that, after first being posted on February 24th 2017, this medical trial is actively seeking volunteers and currently has a sample size of 50 participants from one clinic."
Answered by AI
Is this research endeavor currently actively taking on volunteers?
"Clinicaltrials.gov states that this medical experimentation is currently looking for research subjects, with the initial posting occurring on February 24th 2017 and a recent update from August 2nd 2022."
Answered by AI
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