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
Verified date | August 2020 |
Source | University of Bologna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 4238 |
Est. completion date | December 31, 2019 |
Est. primary completion date | August 31, 2018 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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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 |
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* Note: There are 24 references in all — Click here to view all references
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 |
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