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

U

University of Bologna

Status

Completed

Conditions

Liver Transplant Disorder
HCC

Treatments

Procedure: Liver Transplantation

Study type

Observational

Funder types

Other

Identifiers

NCT04530240
Reg.Pg284644

Details and patient eligibility

About

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).

Full 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.

Enrollment

4,238 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

4,238 participants in 2 patient groups

ERA-1 Group
Description:
Before the introduction of the MELD≥30 allocation scheme August 2010 - July 2014
Treatment:
Procedure: Liver Transplantation
ERA-2 Group
Description:
After the introduction of the MELD≥30 allocation scheme August 2014 - July 2018
Treatment:
Procedure: Liver Transplantation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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