New Prognostic Predictive Models of Mortality of Decompensated Cirrhotic Patients Waiting for Liver Transplantation

NCT ID: NCT03820271

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2023-10-01

Brief Summary

The MELD score is a predictive model of cirrhosis mortality used in France since 2007 to prioritize access to liver transplantation for patients enrolled in the national waiting list. The predictive value of this score was recently revised downward with a C index of the order of 0.65-0.67 and 20% of the patients enrolled for decompensated cirrhosis have access to liver transplantation by a subjective system of "expert component" independent of the MELD because of this lack of precision. The use of the MELD score to individually define access to the transplant should so be reconsidered. Recently new predictive models of cirrhosis mortality better than MELD have been developed and new mortality predictors independent of MELD have been published.

The goal of this study is to design prognostic predictive models of mortality for decompensated cirrhotic patients enrolled on the national liver transplant waiting list including known (MELD, MELD Na) as more recent (CLIF-C AD, CLIF - CACLF) predictive models and new objective predictors studied in combination in order to optimize the system of allocation of hepatic allografts in France.

The expected benefits of this search are twofold:

• At the individual level: The possibility for patients at high risk of death but with intermediate MELD score to be transplanted.
• Public health plan:

• Improving the equity of graft allocation system.
• Decreased mortality in the waiting list by improving the fairness and efficiency of the graft allocation system, a major public health issue

Conditions

Decompensated Cirrhosis; Liver Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

SuperMELD

Group Type: OTHER

SuperMELD

Intervention Type: OTHER

The population of this arm will consist of patients newly enrolled in the National Liver Transplantation Waiting List for decompensated cirrhosis, whose liver function and MELD score are assessed at enrollment and then routinely reassessed at least quarterly during the waiting phase.

Patients will be followed from their listing to transplantation or discharge or death.

Interventions

SuperMELD

The population of this arm will consist of patients newly enrolled in the National Liver Transplantation Waiting List for decompensated cirrhosis, whose liver function and MELD score are assessed at enrollment and then routinely reassessed at least quarterly during the waiting phase.

Patients will be followed from their listing to transplantation or discharge or death.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients (≥18 years old) newly registered on national waiting list with main diagnosis "cirrhosis"
• Patients enrolled on the national waiting list under the "national liver score" allocation scheme whether an expert component is considered or not
• Patients (or trusted person or family member or close relation if the patient is unable to express consent) who have been informed and signed their informed consent
• Patients affiliated to a health insurance scheme

Exclusion Criteria

• Patients enrolled with decompensated cirrhosis associated with hepatocellular carcinoma
• Patients on AVK (INR and therefore MELD and CLIF scores uninterpretable)
• Vulnerable population (person under guardianship or curatorship or deprived of liberty by a judicial decision)
• Pregnant and / or breastfeeding woman

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Candy Estevez

Role: STUDY_CHAIR

APHP DRCI

Laetitia Gregoire

Role: STUDY_CHAIR

APHP URC

Locations

Pr Duvoux

Créteil, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Christophe Duvoux, PHD

Role: CONTACT

christophe.duvoux@aphp.fr

01 49 81 43 28 ext. +33

Facility Contacts

Christophe Duvoux, PhD

Role: primary

christophe.duvoux@aphp.fr

0149814328 ext. +33

Other Identifiers

K170914J

Identifier Type: -

Identifier Source: org_study_id