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

• Sponsor: Roberta Angelico (Other)
• Overall Status: Completed
• CT.gov ID: NCT05662969
• Collaborator: (none)
• Enrollment: 67
• Location: 1
• Actual Duration (Months): 3
• Patients Per Site Per Month: 22.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Organ Preservation Solution	Device: MACHINE PERFUSION

Study Design

• Study Type: Observational
• Actual Enrollment: 67 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Machine-perfusion for Liver Transplantation in High Versus Low/Mid-volume Centres: an International Multicentre Survey
• Actual Study Start Date: Dec 31, 2021
• Actual Primary Completion Date: Jan 31, 2022
• Actual Study Completion Date: Mar 31, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Liver transplant(LT) centres different use of graft after utilization of machine perfusion (MP) [12/2021 - 03/2022]

   High Volume Centers and Low/Mid Volume centers differ in their rates of graft utilization after Machine perfusion

Secondary Outcome Measures

1. Liver Transplant outcomes after Machine Perfusion [12/2021 - 03/2022]

   Reported patient survival rates for Liver Transplant after Machine Perfusion

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Roberta Angelico	Rome		Italy	00133

Sponsors and Collaborators

• Roberta Angelico

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roberta Angelico, Principal investigator, Professor, MD, PhD, FEBS, University of Rome Tor Vergata
• ClinicalTrials.gov Identifier: NCT05662969
• Other Study ID Numbers: MPLTPTV1
• First Posted: Dec 23, 2022
• Last Update Posted: Dec 23, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Roberta Angelico, Principal investigator, Professor, MD, PhD, FEBS, University of Rome Tor Vergata: machine perfusion; liver transplant; low/mid volume transplant center

Study Results

No Results Posted as of Dec 23, 2022