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

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ClinicalTrials.gov Identifier: NCT04530240
Recruitment Status : Completed
First Posted : August 28, 2020
Last Update Posted : August 28, 2020
Sponsor:
Collaborators:
University of Roma La Sapienza
University of Pisa
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Niguarda Hospital
Catholic University of the Sacred Heart
Information provided by (Responsible Party):
Matteo Ravaioli, Professor, University of Bologna

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).

Condition or disease Intervention/treatment
Liver Transplant Disorder HCC Procedure: Liver Transplantation

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.

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Study Type : Observational
Actual Enrollment : 4238 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of National MELD ≥ 30 Priority Allocation System on Dropout and Post-Transplant Survival Rates in Italy: A Retrospective Competing-Risk Analysis
Actual Study Start Date : August 1, 2010
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ERA-1 Group
Before the introduction of the MELD≥30 allocation scheme August 2010 - July 2014
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.

ERA-2 Group
After the introduction of the MELD≥30 allocation scheme August 2014 - July 2018
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.




Primary Outcome Measures :
  1. Patient Survival [ Time Frame: 5 year ]
    Survival since waiting list and after liver transplantation


Secondary Outcome Measures :
  1. Graft Survival [ Time Frame: 5 year ]
    Survival of the graft since liver transplantation



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04530240


Sponsors and Collaborators
University of Bologna
University of Roma La Sapienza
University of Pisa
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Niguarda Hospital
Catholic University of the Sacred Heart
Investigators
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Principal Investigator: Matteo Ravaioli, Professor Sant'Orsola-Malpighi Hospital, University of Bologna
Publications:
Caliendo M, Kopeinig S. Some practical guidance for the implementation of propensity score matching. J Econ Surv. 2008; 22:31-72

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Responsible Party: Matteo Ravaioli, Professor, Professor, University of Bologna
ClinicalTrials.gov Identifier: NCT04530240    
Other Study ID Numbers: Reg.Pg284644
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matteo Ravaioli, Professor, University of Bologna:
Allocation System
Liver Transplantation