NCT02940600

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

1.5 years

First QC Date

October 16, 2016

Last Update Submit

October 19, 2016

Conditions

Ischemic Reperfusion Injury

Keywords

normothermic perfusionold donorsextended criteria graftsreconditioning

Outcome Measures

Primary Outcomes (1)

  • 6 months graft survival

    180 days

Secondary Outcomes (3)

  • Ischemia-reperfusion injury assessment through biopsies evaluation

    1 day

  • ischemia reperfusion injury assessment through transaminases

    7 days

  • Ischemia reperfusion injury assessment through incidence of ischemic type biliary lesions

    180 days

Study Arms (2)

Normothermic machine perfusion

EXPERIMENTAL

Patients undergoing liver transplant with grafts preserved using normothermic machine perfusion

Device: Normothermic machine perfusion

Static cold storage

ACTIVE COMPARATOR

Patients undergoing liver transplant with statically cold preserved grafts

Procedure: Static cold storage

Interventions

Normothermic machine perfusionDEVICE

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

Also known as: Liver Assist
Normothermic machine perfusion
Static cold storagePROCEDURE

Patients undergoing liver transplant using statically cold preserved grafts

Static cold storage

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UO Chirurgia Epatica e del Trapianto di Fegato

Pisa, Pisa, 56124, Italy

RECRUITING

Related Publications (4)

  • 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.

    PMID: 27639262BACKGROUND

  • 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.

    PMID: 27192971BACKGROUND

  • 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.

    PMID: 26946466BACKGROUND

  • 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.

    PMID: 26752191BACKGROUND

Study Officials

  • Davide Ghinolfi, MD, PhD

    Azienda Ospedaliero, Universitaria Pisana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Davide Ghinolfi, MD, PhD

CONTACT

+39050995421d.ghinolfi@ao-pisa.toscana.it

Daniele Pezzati, MD

CONTACT

+393202172957danypez@hotmail.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

October 16, 2016

First Posted

October 21, 2016

Study Start

October 1, 2016

Primary Completion

April 1, 2018

Study Completion

October 1, 2018

Last Updated

October 21, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)