End-stage Liver Disease
Conditions
Keywords
Deceased donor liver transplant, Normothermic machine perfusion
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.
Interventions
DEVICEOrganOx Metra
Normothermic machine perfusion (NMP) Metra device
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of primary graft non-function | 3 months |
| Rates of re-transplantation | 3 months |
| Rates of recipient death | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The function of liver grafts stored with the Metra™ device | 3 months | Measured by bilirubin, alkaline phosphatase, AST and INR levels at days 1-7 post-transplant. The measure is a composite. |
| Rate of device failures resulting in organ discard | 3 months | — |
| The ability of perfusion parameters to predict clinical outcomes following transplantation | 3 months | Perfusion flows and pressures will be studied to determine their correlation with graft injury and function. The measure is a composite. |
| Recruitment rates to the study | 3 months | Measured by the ratio of actual / eligible candidate donors recruited to the study |
| Ischemia- reperfusion injury associated with organ storage | 7 days | Assessed by a post-perfusion biopsy |
Countries
Canada
Outcome results
None listed