NCT04530240

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
• Phase: —
• Study type: Observational
• Enrollment: 4,238 (actual)
• Sponsor: University of Bologna · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Conditions

• Liver Transplant Disorder
• HCC

Interventions

Type	Name	Description
PROCEDURE	Liver 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.

Timeline

• Start date: 2010-08-01
• Primary completion: 2018-08-31
• Completion: 2019-12-31
• First posted: 2020-08-28
• Last updated: 2020-08-28