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Equity and Efficacy of Allocation Priority for Liver Transplantation Patients With MELD≥30 in Italy

Impact of National MELD ≥ 30 Priority Allocation System on Dropout and Post-Transplant Survival Rates in Italy: A Retrospective Competing-Risk Analysis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04530240
Enrollment
4238
Registered
2020-08-28
Start date
2010-08-01
Completion date
2019-12-31
Last updated
2020-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCC, Liver Transplant Disorder

Keywords

Allocation System, Liver Transplantation

Brief summary

In Italy, since August 2014, liver transplantation (LT) candidates with MELD≥30 receive a priority allocation consenting them to access in an organ sharing macroarea. The primary intent of this policy is to minimize the higher risk of waiting list dropout observed in these patients. Another objective of this allocation strategy is to reduce the waiting time, thus performing the LT in better clinical conditions. This multicentre retrospective national study aims to evaluate several parameters of efficacy and equity, such as waiting time in the list, dropout rate, and graft survival, in two eras of enlisted patients, before and after the introduction of the macroarea sharing policy in Italy. With the intent to minimize the presence of possible selection biases, the two groups were matched trough Propensity Score Matching (PSM).

Detailed description

A retrospective multi-centre study involving six Italian transplant centres was performed using prospectively collected databases from each participating centre, registering MELD score recorded at the time of drop-out, liver transplantation and end of the follow-up. Study population was divided in two groups according to the time of waiting list before or after the introduction of MELD ≥ 30 allocation scheme: ERA-1 Group (August 2010 - July 2014), and ERA-2 Group (August 2014 - July 2018). Primary endpoint was waiting list time across different eras in patients above and below MELD ≥ 30 cutoff. Secondary endpoints were dropout rate as well as patient and graft survival.

Interventions

PROCEDURELiver Transplantation

Use prospectively collected databases from each participate centre, register MELD score recorded at the time of drop-out, liver transplantation and end of the follow-up.

Sponsors

University of Roma La Sapienza
CollaboratorOTHER
University of Pisa
CollaboratorOTHER
A.O.U. Città della Salute e della Scienza
CollaboratorOTHER
Niguarda Hospital
CollaboratorOTHER
Catholic University of the Sacred Heart
CollaboratorOTHER
University of Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

\- LT patients registered from August 2010 to July 2018

Exclusion criteria

* LT patients registered before August 2010 and after July 2018 * Data not available for analysis

Design outcomes

Primary

MeasureTime frameDescription
Patient Survival5 yearSurvival since waiting list and after liver transplantation

Secondary

MeasureTime frameDescription
Graft Survival5 yearSurvival of the graft since liver transplantation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026