Organ Preservation SolutionMP-LTxNCT05662969
Machine Perfusion in High vs Low/Mid-volume Liver Transplant Centers: a Multicentre Survey
An observational study of Organ Preservation Solution, run by Roberta Angelico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Organ Preservation Solution
- What is being tested?
- MACHINE PERFUSION
- Type of treatment
- Medical device
- How many people
- 67 participants
- Where
- 1 siteItaly
- Study dates
- 31 Dec 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older 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)
Who may be able to join
- 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
Who cannot join
- LT centres that not use MP
- LT centres that use MP but on clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Organ Preservation Solution
- Being tested
- MACHINE PERFUSION
- Keywords
- machine perfusion, liver transplant, low/mid volume transplant center
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MACHINE PERFUSIONDevice
Different outcomes of MP use in low/mid-volume and high-volume LT centres
| Study group | Role | What they receive |
|---|---|---|
| Low/mid-volume liver transplant centres | Not described Receives: Device: MACHINE PERFUSION | |
| High-volume liver transplant centres | Not described Receives: Device: MACHINE PERFUSION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12/2021 - 03/2022
Secondary outcomes (1)
Liver Transplant outcomes after Machine Perfusion
Reported patient survival rates for Liver Transplant after Machine Perfusion
Measured: 12/2021 - 03/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start31 Dec 2021
- Primary completion31 Jan 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ Preservation SolutionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roberta Angelico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roberta Angelico, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662969
- Sponsor's protocol ID
- MPLTPTV1
- Acronym
- MP-LTx
- Status last verified
- Dec 2022
- First submitted
- 29 Nov 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine-perfusion for Liver Transplantation in High Versus Low/Mid-volume Centres: an International Multicentre Survey
- ClinicalTrials.gov ID
- NCT05662969
- Acronym / sponsor ID
- MP-LTx / MPLTPTV1
- Conditions
- Organ Preservation Solution
- Keywords
- machine perfusion, liver transplant, low/mid volume transplant center
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Roberta AngelicoUniversity, hospital or other
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low/mid-volume liver transplant centres | – | Device: MACHINE PERFUSION |
| High-volume liver transplant centres | – | Device: MACHINE PERFUSION |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older 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)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- LT centres that not use MP
- LT centres that use MP but on clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MACHINE PERFUSIONDifferent outcomes of MP use in low/mid-volume and high-volume LT centres | Device | High-volume liver transplant centres, Low/mid-volume liver transplant centres |
Primary outcome
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
1 secondary outcome
Liver Transplant outcomes after Machine Perfusion
Time frame: 12/2021 - 03/2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Organ Preservation Solution, run by Roberta Angelico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver transplant(LT) centres different use of graft after utilization of machine perfusion (MP) (time frame: 12/2021 - 03/2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.