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

University Health Network, Toronto

Status and phase: Unknown; Phase 1

Conditions: End-stage Liver Disease

Treatments: Device: OrganOx Metra

Study type: Interventional

Funder types: Other

Identifiers

NCT02478151

14-8132-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

OrganOx Metra

Experimental group

Description:

OrganOx Metra Device

Treatment:

Device: OrganOx Metra