Using Ex-vivo Normothermic Machine Perfusion With the Organox Metra™ Device to Store Human Livers for Transplantation

Phase 1

• Conditions: End-stage Liver Disease
• Interventions: Device: OrganOx Metra

• Registration Number: NCT02478151
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Liver transplantation is a life-saving procedure but its success has been limited by a shortage of suitable donor organs. Much emphasis is now placed on optimising the condition of those organs that are available, to enable more higher risk organs to be transplanted safely. An effective means of pre-transplant viability assessment would not only allow greater use of higher risk donors but also minimise the risk of primary non-function by identifying and excluding non-viable organs before subjecting a patient to the risk of surgery. Organ storage under normothermic perfusion conditions enables organ function to be evaluated prior to transplantation and further has been shown to prevent organ injury which is sustained during standard cold storage. 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. This study will evaluate liver function post-transplantation using standard clinical parameters. Participants will be followed for 3 months following transplantation and their outcomes recorded. Participants will undergo no other study procedures. Feasibility will be measured using the ratio of actual / eligible candidate donors recruited to the study and will also encompass logistical issues with respect to transportation, and ease of use. Safety will be assessed by rates of device failures resulting in organ discard, primary graft non-function, re-transplantation, and recipient death.

Study Timeline

• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2015-06-17
• Study First Posted: 2015-06-23
• Study Start: 2015-07
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-08
• Last Update Posted: 2022-04-12
• Primary Completion: 2022-12
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OrganOx Metra	OrganOx Metra	OrganOx Metra Device

Primary Outcome Measures

Name	Time	Method
Rates of recipient death	3 months
Rates of primary graft non-function	3 months
Rates of re-transplantation	3 months

Secondary Outcome Measures

Name	Time	Method
Recruitment rates to the study	3 months	Measured by the ratio of actual / eligible candidate donors recruited to the study
Rate of device failures resulting in organ discard	3 months
The ability of perfusion parameters to predict clinical outcomes following transplantation	3 months	Bile production will be studied to determine their correlation with graft injury and function
Ischemia- reperfusion injury associated with organ storage	7 days	Assessed by measuring the peak serum aspartate transaminase level (AST) within 7 days post-transplant
The function of liver grafts stored with the Metra™ device	3 months	Measured by Lactate at days 1-3 post-transplant. The measure is a composite.

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada