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

Azienda Ospedaliero, Universitaria Pisana

Status: Unknown

Conditions: Ischemic Reperfusion Injury

Treatments: Device: Normothermic machine perfusion; Procedure: Static cold storage

Study type: Interventional

Funder types: Other

Identifiers

NCT02940600

687

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Normothermic machine perfusion

Experimental group

Description:

Patients undergoing liver transplant with grafts preserved using normothermic machine perfusion

Treatment:

Device: Normothermic machine perfusion

Static cold storage

Active Comparator group

Description:

Patients undergoing liver transplant with statically cold preserved grafts

Treatment:

Procedure: Static cold storage