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

Assistance Publique - Hôpitaux de Paris

Status

Unknown

Conditions

Liver Transplantation

Decompensated Cirrhosis

Treatments

Other: SuperMELD

Study type

Interventional

Funder types

Other

Identifiers

NCT03820271

K170914J

Details and patient eligibility

About

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

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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