Pr Duvoux
Créteil, 94000, France
NCT Number: NCT03820271
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 * An ancillary study to the SUPERMELD study is also proposed, the miR MELD study, whose main objective is to evaluate the value of plasma miRNAs in a cohort of patients with decompensated cirrhosis (acute and chronic, excluding cancer) listed for liver transplantation to predict 3-month mortality on the liver transplant waiting list or drop-out from the waitlist for being too sick.
Additional data collection of the vital status 1 year after transplantation of patients initially included in the SUPERMELD study will also be added for all transplanted patients to assess the potential acceleration of access to transplantation for certain candidates at high risk of death prior to transplantation on post-transplantation survival, and assess the transplant benefit.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Créteil, 94000, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Month 3.
Predictive value of mortality and drop out in the waiting list
Time frame: Month 3. Month 6, Month 9, Month 12Month 12
CRP, copeptin, NT-pro BNP, vitamin D, leucocytes, PMN/lymphocytes ratio, urinary NGal, cystatin C, frailty index, sarcopenia (abdominal tomodensitometry to measure the surface of psoas), caloric intake, encephalopathy (ammonia level, stroop application), and transferrin.
Time frame: Month 3 Month 6, Month 9, Month 12.Month 12
infection, renal dysfunction, encephalopathy, bleeding, ACLF
Time frame: Months 3, Month 6, Month 9, Month 12.
Time frame: Months 3, Month 6, Month 9, Month 12.
death and drop out
Time frame: Month 6
Identification of microRNA signatures with independent predictive value of MELD for mortality/drop out from the waitlist
Assistance Publique - Hôpitaux de Paris
Other
Construction of New Predictive Mathematical Models of Mortality in Decompensated Cirrhotic Patients Who Are Candidates for Liver Transplantation
Acronym: SUPERMELD
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