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

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

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

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.

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