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临床试验/NCT04530240
NCT04530240已完成不适用

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

University of Bologna0 个研究点目标入组 4,238 人开始时间: 2010年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4,238
主要终点
Patient Survival

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •LT patients registered from August 2010 to July 2018

排除标准

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

结局指标

主要结局

Patient Survival

时间窗: 5 year

Survival since waiting list and after liver transplantation

次要结局

  • Graft Survival(5 year)

研究者

发起方
University of Bologna
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matteo Ravaioli, Professor

Professor

University of Bologna

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