Clinical trial NCT04530240: Equity and Efficacy of Allocation Priority for Liver Transplantation Patients With MELD≥30 in Italy
Official title: Impact of National MELD ≥ 30 Priority Allocation System on Dropout and Post-Transplant Survival Rates in Italy: A Retrospective Competing-Risk Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant Disorder
HCC
Keywords: Allocation System
Liver Transplantation
Lead sponsor: University of Bologna
Sponsor class: OTHER
Collaborators: name: University of Roma La Sapienza
name: University of Pisa
name: A.O.U. Città della Salute e della Scienza
name: Niguarda Hospital
name: Catholic University of the Sacred Heart
First posted: 2020-08-28
Enrollment: 4238
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 4,238 LT patients registered from August 2010 to July 2018 have been initially enrolled for the analysis (Bologna=961, Pisa=980, Turin=897, Milan Niguarda=859, Rome Sapienza=268, Rome Cattolica=273), and categorized in an ERA-1 Group (n=2,225; before macroarea priority allocation), and an ERA-2 Group (n=2,013; after macroarea priority allocation).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Survival
timeFrame: 5 year
Secondary outcomes:
measure: Graft Survival
timeFrame: 5 year
Other outcomes:
Locations:
Study officials:
affiliation: Sant'Orsola-Malpighi Hospital, University of Bologna
name: Matteo Ravaioli, Professor
role: PRINCIPAL_INVESTIGATOR
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