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

HCC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04530240
• Other study ID #: Reg.Pg284644
• Status: Completed
• Start date: August 1, 2010
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2020
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4238
• Est. completion date: December 31, 2019
• Est. primary completion date: August 31, 2018
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• HCC
• Liver Transplant Disorder

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
University of Bologna	Azienda Ospedaliera Città della Salute e della Scienza di Torino, Catholic University of the Sacred Heart, Niguarda Hospital, University of Pisa, University of Roma La Sapienza

References & Publications (24)

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Cillo U, Burra P, Mazzaferro V, Belli L, Pinna AD, Spada M, Nanni Costa A, Toniutto P; I-BELT (Italian Board of Experts in the Field of Liver Transplantation). A Multistep, Consensus-Based Approach to Organ Allocation in Liver Transplantation: Toward a "Blended Principle Model". Am J Transplant. 2015 Oct;15(10):2552-61. doi: 10.1111/ajt.13408. Epub 2015 Aug 14. — View Citation

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Sundaram V, Kogachi S, Wong RJ, Karvellas CJ, Fortune BE, Mahmud N, Levitsky J, Rahimi RS, Jalan R. Effect of the clinical course of acute-on-chronic liver failure prior to liver transplantation on post-transplant survival. J Hepatol. 2020 Mar;72(3):481-488. doi: 10.1016/j.jhep.2019.10.013. Epub 2019 Oct 25. — View Citation

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Weismüller TJ, Fikatas P, Schmidt J, Barreiros AP, Otto G, Beckebaum S, Paul A, Scherer MN, Schmidt HH, Schlitt HJ, Neuhaus P, Klempnauer J, Pratschke J, Manns MP, Strassburg CP. Multicentric evaluation of model for end-stage liver disease-based allocation and survival after liver transplantation in Germany--limitations of the 'sickest first'-concept. Transpl Int. 2011 Jan;24(1):91-9. doi: 10.1111/j.1432-2277.2010.01161.x. Epub 2010 Sep 3. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Survival	Survival since waiting list and after liver transplantation	5 year
Secondary	Graft Survival	Survival of the graft since liver transplantation	5 year