Machine Perfusion in High vs Low/Mid-volume Liver Transpl... | NCT05662969

Studies
Machine Perfusion in High vs Low/Mid-volume Liver Transplant Centers: a Multicentre Survey

NCT05662969

Sponsor

Roberta Angelico

Status

Completed

Last Update Posted

Dec 23, 2022Actual

Enrollment

67Actual

Phase

Not provided

Conditions

Organ Preservation Solution

Interventions

MACHINE PERFUSION

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 31, 2021Actual

Primary Completion Date

Jan 31, 2022Actual

Completion Date

Mar 31, 2022Actual

First Submitted Date

Nov 29, 2022

First Submission Date that Met QC Criteria

Dec 20, 2022

First Posted Date

Dec 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2022

Last Update Posted Date

Dec 23, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Roberta Angelico, Principal investigator, Professor, MD, PhD, FEBS, University of Rome Tor VergataSponsor-Investigator

Lead Sponsor

Roberta AngelicoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low/mid-volume liver transplant centres			Device: MACHINE PERFUSION
High-volume liver transplant centres			Device: MACHINE PERFUSION

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MACHINE PERFUSION	Device	Different outcomes of MP use in low/mid-volume and high-volume LT centres	High-volume liver transplant centres Low/mid-volume liver transplant centres

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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)

Sampling Method

Probability Sample