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

Ischemic Reperfusion Injury Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Reperfusion Injury
• Reperfusion Injury

• NCT number: NCT02940600
• Study type: Interventional
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: Davide Ghinolfi, MD, PhD
• Phone: +39050995421
• Email: d.ghinolfi@ao-pisa.toscana.it
• Status: Recruiting
• Phase: N/A
• Start date: October 2016
• Completion date: October 2018