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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-10-31

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

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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.

Conditions

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Ischemic Reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normothermic machine perfusion

Patients undergoing liver transplant with grafts preserved using normothermic machine perfusion

Group Type EXPERIMENTAL

Normothermic machine perfusion

Intervention Type DEVICE

Patients undergoing liver transplant with the use of grafts preserved with normothermic perfusion machine

Static cold storage

Patients undergoing liver transplant with statically cold preserved grafts

Group Type ACTIVE_COMPARATOR

Static cold storage

Intervention Type PROCEDURE

Patients undergoing liver transplant using statically cold preserved grafts

Interventions

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Normothermic machine perfusion

Patients undergoing liver transplant with the use of grafts preserved with normothermic perfusion machine

Intervention Type DEVICE

Static cold storage

Patients undergoing liver transplant using statically cold preserved grafts

Intervention Type PROCEDURE

Other Intervention Names

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Liver Assist

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No