Efficacy Evaluation of Normothermic Perfusion Machine Preservation in Liver Transplant Using Very Old Donors

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the impact of normothermic machine perfusion in liver transplantation using grafts of brain death donors older or equal than 70 years

Detailed Description
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Mean donor age for liver transplantation in Tuscany, Italy, is increasing and is actually 71 years. Old donors are a valuable resource but their use has been related to a major incidence of primary non function (PNF), delayed graft function (DGF) and ischemic type biliary lesions (ITBL). Ischemia-reperfusion injury is a major reason for the development of these complications and and old grafts are more susceptible than younger ones. Normothermic machine perfusion (NMP) is a novel and promising technique that allows preservation in a more physiological environment. It is our belief that the use of NMP might reduce the impact of ischemia-reperfusion injuries in older grafts thus reducing the incidence of complications and providing a better outcome.

Official Title
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Pilot, Open, Monocentric, Randomized, Prospective Trial for the Evaluation of the Efficacy of Normothermic Perfusion Machine for Organ Preservation in Liver Transplantation Using Brain Death Donors Older or Equal Than 70 Years

Conditions
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Ischemic Reperfusion Injury

Intervention / Treatment
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* Device: Normothermic machine perfusion
* Procedure: Static cold storage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient on waiting list for liver transplant Signed informed consent Age between 18 and 70 Eligibility for liver transplant as for University of Pisa Liver Transplant Center Protocol Capacity and willingness to participate to the protocol Exclusion Criteria: No signed informed consent Age under 18 or over 70 Presence of disease that may influence results Patient participation to other studies Re-liver transplant ABO incompatible OLT Multiorgan transplant Liver transplant for acute liver failure or trauma MELD (model for end stage liver disease) >24 Patient not suitable to participate on investigators's opinion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normothermic machine perfusion<br>Patients undergoing liver transplant with grafts preserved using normothermic machine perfusion | Device: Normothermic machine perfusion<br>* Patients undergoing liver transplant with the use of grafts preserved with normothermic perfusion machine<br>* Other names: Liver Assist;|
| Active Comparator: Static cold storage<br>Patients undergoing liver transplant with statically cold preserved grafts | Procedure: Static cold storage<br>* Patients undergoing liver transplant using statically cold preserved grafts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 months graft survival |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemia-reperfusion injury assessment through biopsies evaluation |  | 1 day | 
| ischemia reperfusion injury assessment through transaminases | AST level at post operative day number 7 | 7 days | 
| Ischemia reperfusion injury assessment through incidence of ischemic type biliary lesions |  | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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normothermic perfusion, old donors, extended criteria grafts, reconditioning