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

NCT05662969 | Completed FDA Device

• 1 other identifier: MPLTPTV1
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Organ Preservation Solution

Keywords

machine perfusion; liver transplant; low/mid volume transplant center

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Liver Transplant outcomes after Machine Perfusion

  12/2021 - 03/2022

Study Arms (2)

Low/mid-volume liver transplant centres

Device: MACHINE PERFUSION

High-volume liver transplant centres

Device: MACHINE PERFUSION

Interventions

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

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Roberta Angelico: lead

Study Sites (1)

Roberta Angelico

Rome, 00133, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator, Professor, MD, PhD, FEBS

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 23, 2022
• Study Start: December 31, 2021
• Primary Completion: January 31, 2022
• Study Completion: March 31, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-12

Locations

IT (1)