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

End-stage Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02478151
• Other study ID #: 14-8132-B
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: July 2015
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: March 31, 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Liver Disease
• End-stage Liver Disease
• Liver Diseases

Intervention

Device:
• OrganOx Metra
Normothermic machine perfusion (NMP) Metra device

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of primary graft non-function		3 months
Primary	Rates of re-transplantation		3 months
Primary	Rates of recipient death		3 months
Secondary	Rate of device failures resulting in organ discard		3 months
Secondary	Recruitment rates to the study	Measured by the ratio of actual / eligible candidate donors recruited to the study	3 months
Secondary	Ischemia- reperfusion injury associated with organ storage	Assessed by a post-perfusion biopsy	7 days
Secondary	Ischemia- reperfusion injury associated with organ storage	Assessed by measuring the peak serum aspartate transaminase level (AST) within 7 days post-transplant	7 days
Secondary	The function of liver grafts stored with the Metra™ device	Measured by bilirubin, alkaline phosphatase, AST and INR levels at days 1-7 post-transplant. The measure is a composite.	3 months
Secondary	The function of liver grafts stored with the Metra™ device	Measured by bilirubin, alkaline phosphatase, AST and INR levels at day 30 post-transplant. The measure is a composite.	3 months
Secondary	The function of liver grafts stored with the Metra™ device	Measured by bilirubin, alkaline phosphatase, AST and INR levels at month 3 post-transplant. The measure is a composite.	3 months
Secondary	The function of liver grafts stored with the Metra™ device	Measured by Lactate at days 1-3 post-transplant. The measure is a composite.	3 months
Secondary	The ability of perfusion parameters to predict clinical outcomes following transplantation	Perfusion flows and pressures will be studied to determine their correlation with graft injury and function. The measure is a composite.	3 months
Secondary	The ability of perfusion parameters to predict clinical outcomes following transplantation	Perfusate blood gas parameters will be studied to determine their correlation with graft injury and function. The measure is a composite.	3 months
Secondary	The ability of perfusion parameters to predict clinical outcomes following transplantation	Bile production will be studied to determine their correlation with graft injury and function	3 months