Machine Perfusion in High vs Low/Mid-volume Liver Transplant Centers: a Multicentre Survey (MP-LTx)

December 20, 2022 updated by: Roberta Angelico

Machine-perfusion for Liver Transplantation in High Versus Low/Mid-volume Centres: an International Multicentre Survey

Introduction: Machine perfusion (MP) was developed to expand the available donor pool and to improve liver transplantation outcomes. Despite optimal results in clinical trials, MP benefit outside of clinical experimentation in unknown. Low/mid volume centres (L/MVCs) may face logistical/economical difficulties that may in turn hamper optimal MP results.

Methods: An Online 22-item survey on the use of machine perfusion for liver transplantation outside of clinical trials, was distributed to worldwide LT centres representatives. Variables of interest included MP logistics, MP technicalities, MP results, post-MP LT results. Responding centres were grouped into high volume centre (HVCs)(defined as >60 LTs per year in 2019) and L/MVCs. Results from HVCs vs L/MVCs were compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

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

Study Locations

  • Italy
      • Rome, Italy, 00133
        • Roberta Angelico

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

67 LT centres divided by a cutoff of 60LT/year in: 31 low/mid-volume LT centres (<60LT/year) and 36 high-volume LT centres (>60 LT/year)

Description

Inclusion Criteria:

  • LT centres that use MP
  • LT centres which perform LT before pandemic time (before 2019 included)
  • LT centres which perform LT from cadaveric donors and living donors

Exclusion Criteria:

  • LT centres that not use MP
  • LT centres that use MP but on clinical trials

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low/mid-volume liver transplant centres
Device: MACHINE PERFUSION
Different outcomes of MP use in low/mid-volume and high-volume LT centres
High-volume liver transplant centres
Device: MACHINE PERFUSION
Different outcomes of MP use in low/mid-volume and high-volume LT centres

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver transplant(LT) centres different use of graft after utilization of machine perfusion (MP)
Time Frame: 12/2021 - 03/2022
High Volume Centers and Low/Mid Volume centers differ in their rates of graft utilization after Machine perfusion
12/2021 - 03/2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver Transplant outcomes after Machine Perfusion
Time Frame: 12/2021 - 03/2022
Reported patient survival rates for Liver Transplant after Machine Perfusion
12/2021 - 03/2022

Collaborators and Investigators

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

Sponsor

Roberta Angelico

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 (Actual)

December 31, 2021

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

November 29, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Estimate)

December 23, 2022

Study Record Updates

Last Update Posted (Estimate)

December 23, 2022

Last Update Submitted That Met QC Criteria

December 20, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MPLTPTV1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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.

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