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

October 19, 2016 updated by: Davide Ghinolfi, Azienda Ospedaliero, Universitaria Pisana

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Pisa, Italy, 56124
        • Recruiting
        • UO Chirurgia Epatica e del Trapianto di Fegato
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normothermic machine perfusion
Patients undergoing liver transplant with grafts preserved using normothermic machine perfusion
Device: Normothermic machine perfusion
Patients undergoing liver transplant with the use of grafts preserved with normothermic perfusion machine
Other Names:
  • Liver Assist
Active Comparator: Static cold storage
Patients undergoing liver transplant with statically cold preserved grafts
Procedure: Static cold storage
Patients undergoing liver transplant using statically cold preserved grafts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
6 months graft survival
Time Frame: 180 days
180 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero, Universitaria Pisana

Investigators

  • Principal Investigator: Davide Ghinolfi, MD, PhD, Azienda Ospedaliero, Universitaria Pisana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

October 16, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Estimate)

October 21, 2016

Last Update Submitted That Met QC Criteria

October 19, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 687

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ischemic Reperfusion Injury

Clinical Trials on Normothermic machine perfusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe