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

Primary Purpose

Ischemic Reperfusion Injury

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Normothermic machine perfusion
Static cold storage
Sponsored by
Azienda Ospedaliero, Universitaria Pisana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Reperfusion Injury focused on measuring normothermic perfusion, old donors, extended criteria grafts, reconditioning

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UO Chirurgia Epatica e del Trapianto di FegatoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Normothermic machine perfusion

Static cold storage

Arm Description

Patients undergoing liver transplant with grafts preserved using normothermic machine perfusion

Patients undergoing liver transplant with statically cold preserved grafts

Outcomes

Primary Outcome Measures

6 months graft survival

Secondary Outcome Measures

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

Full Information

First Posted
October 16, 2016
Last Updated
October 19, 2016
Sponsor
Azienda Ospedaliero, Universitaria Pisana
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1. Study Identification

Unique Protocol Identification Number
NCT02940600
Brief Title
Efficacy Evaluation of Normothermic Perfusion Machine Preservation in Liver Transplant Using Very Old Donors
Acronym
CEFEMA
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero, Universitaria Pisana

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Reperfusion Injury
Keywords
normothermic perfusion, old donors, extended criteria grafts, reconditioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normothermic machine perfusion
Arm Type
Experimental
Arm Description
Patients undergoing liver transplant with grafts preserved using normothermic machine perfusion
Arm Title
Static cold storage
Arm Type
Active Comparator
Arm Description
Patients undergoing liver transplant with statically cold preserved grafts
Intervention Type
Device
Intervention Name(s)
Normothermic machine perfusion
Other Intervention Name(s)
Liver Assist
Intervention Description
Patients undergoing liver transplant with the use of grafts preserved with normothermic perfusion machine
Intervention Type
Procedure
Intervention Name(s)
Static cold storage
Intervention Description
Patients undergoing liver transplant using statically cold preserved grafts
Primary Outcome Measure Information:
Title
6 months graft survival
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Ischemia-reperfusion injury assessment through biopsies evaluation
Time Frame
1 day
Title
ischemia reperfusion injury assessment through transaminases
Description
AST level at post operative day number 7
Time Frame
7 days
Title
Ischemia reperfusion injury assessment through incidence of ischemic type biliary lesions
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Davide Ghinolfi, MD, PhD
Phone
+39050995421
Email
d.ghinolfi@ao-pisa.toscana.it
First Name & Middle Initial & Last Name or Official Title & Degree
Daniele Pezzati, MD
Phone
+393202172957
Email
danypez@hotmail.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davide Ghinolfi, MD, PhD
Organizational Affiliation
Azienda Ospedaliero, Universitaria Pisana
Official's Role
Principal Investigator
Facility Information:
Facility Name
UO Chirurgia Epatica e del Trapianto di Fegato
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Davide Ghinolfi, MD
Phone
+39050995421
Email
d.ghinolfi@ao-pisa.toscana.it
First Name & Middle Initial & Last Name & Degree
Daniele Pezzati, MD
Phone
+393202172957
Email
danypez@hotmail.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27639262
Citation
Bral M, Gala-Lopez B, Bigam D, Kneteman N, Malcolm A, Livingstone S, Andres A, Emamaullee J, Russell L, Coussios C, West LJ, Friend PJ, Shapiro AM. Preliminary Single-Center Canadian Experience of Human Normothermic Ex Vivo Liver Perfusion: Results of a Clinical Trial. Am J Transplant. 2017 Apr;17(4):1071-1080. doi: 10.1111/ajt.14049. Epub 2016 Dec 9.
Results Reference
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PubMed Identifier
27192971
Citation
Mergental H, Perera MT, Laing RW, Muiesan P, Isaac JR, Smith A, Stephenson BT, Cilliers H, Neil DA, Hubscher SG, Afford SC, Mirza DF. Transplantation of Declined Liver Allografts Following Normothermic Ex-Situ Evaluation. Am J Transplant. 2016 Nov;16(11):3235-3245. doi: 10.1111/ajt.13875. Epub 2016 Jul 13.
Results Reference
background
PubMed Identifier
26946466
Citation
Op den Dries S, Karimian N, Westerkamp AC, Sutton ME, Kuipers M, Wiersema-Buist J, Ottens PJ, Kuipers J, Giepmans BN, Leuvenink HG, Lisman T, Porte RJ. Normothermic machine perfusion reduces bile duct injury and improves biliary epithelial function in rat donor livers. Liver Transpl. 2016 Jul;22(7):994-1005. doi: 10.1002/lt.24436.
Results Reference
background
PubMed Identifier
26752191
Citation
Ravikumar R, Jassem W, Mergental H, Heaton N, Mirza D, Perera MT, Quaglia A, Holroyd D, Vogel T, Coussios CC, Friend PJ. Liver Transplantation After Ex Vivo Normothermic Machine Preservation: A Phase 1 (First-in-Man) Clinical Trial. Am J Transplant. 2016 Jun;16(6):1779-87. doi: 10.1111/ajt.13708. Epub 2016 Mar 7.
Results Reference
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Efficacy Evaluation of Normothermic Perfusion Machine Preservation in Liver Transplant Using Very Old Donors

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