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OpenTrials
Completed

NCT Number: NCT04530240

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

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).

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Key information

Conditions

Liver Transplant Disorder HCC

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liver Transplantation

Procedure

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.

Primary outcomes

  1. Patient Survival

    Time frame: 5 year

    Survival since waiting list and after liver transplantation

Secondary outcomes

  1. Graft Survival

    Time frame: 5 year

    Survival of the graft since liver transplantation

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2018
Study completion
2019
First posted
Aug 28, 2020
Registry last updated
Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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