Clinical trial NCT02478151: Using Ex-vivo Normothermic Machine Perfusion With the Organox Metra™ Device to Store Human Livers for Transplantation
Official title: A Single Centre Study of the Feasibility and Safety of Using Ex-vivo Normothermic Machine Perfusion With the Organox Metra™ Device to Store Human Livers for Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: End-stage Liver Disease
Keywords: Deceased donor liver transplant
Normothermic machine perfusion
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rates of primary graft non-function
timeFrame: 3 months
measure: Rates of re-transplantation
timeFrame: 3 months
measure: Rates of recipient death
timeFrame: 3 months
Secondary outcomes:
measure: Rate of device failures resulting in organ discard
timeFrame: 3 months
measure: Recruitment rates to the study
timeFrame: 3 months
measure: Ischemia- reperfusion injury associated with organ storage
timeFrame: 7 days
measure: Ischemia- reperfusion injury associated with organ storage
timeFrame: 7 days
measure: The function of liver grafts stored with the Metra™ device
timeFrame: 3 months
measure: The function of liver grafts stored with the Metra™ device
timeFrame: 3 months
measure: The function of liver grafts stored with the Metra™ device
timeFrame: 3 months
measure: The function of liver grafts stored with the Metra™ device
timeFrame: 3 months
measure: The ability of perfusion parameters to predict clinical outcomes following transplantation
timeFrame: 3 months
measure: The ability of perfusion parameters to predict clinical outcomes following transplantation
timeFrame: 3 months
measure: The ability of perfusion parameters to predict clinical outcomes following transplantation
timeFrame: 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: David R Grant, MD
role: PRINCIPAL_INVESTIGATOR
References: