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

Not Applicable

• Conditions: Ischemic Reperfusion Injury
• Interventions: Device: Normothermic machine perfusion; Procedure: Static cold storage

• Registration Number: NCT02940600
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

Brief 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

Detailed 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 Timeline

• Status Verified: 2016-10
• Study Start: 2016-10
• Study First Submitted: 2016-10-16
• Study First Submitted QC: 2016-10-19
• Last Update Submitted: 2016-10-19
• Study First Posted: 2016-10-21
• Last Update Posted: 2016-10-21
• Primary Completion: 2018-04
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normothermic machine perfusion	Normothermic machine perfusion	Patients undergoing liver transplant with grafts preserved using normothermic machine perfusion
Static cold storage	Static cold storage	Patients undergoing liver transplant with statically cold preserved grafts

Primary Outcome Measures

Name	Time	Method
6 months graft survival	180 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UO Chirurgia Epatica e del Trapianto di Fegato; 🇮🇹 Pisa, Italy