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

Not Applicable

• Conditions: Liver Transplantation; Decompensated Cirrhosis
• Interventions: Other: SuperMELD

• Registration Number: NCT03820271
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-18
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-29
• Study Start: 2020-10-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-03
• Primary Completion: 2022-10-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SuperMELD	SuperMELD	-

Primary Outcome Measures

Name	Time	Method
predictive value of the new multivariate prognostic models in patients listed for decompensated cirrhosis	Month 3.	Predictive value of mortality and drop out in the waiting list

Secondary Outcome Measures

Name	Time	Method
Added predictive value for mortality and drop out of new multivariate prognostic models on MELD (model end stage for liver disease)	Months 3, Month 6, Month 9, Month 12.
Individual predictive value of each of the new candidate predictors	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.
Complications predicted by each of the independent predictors	Month 3 Month 6, Month 9, Month 12.Month 12	infection, renal dysfunction, encephalopathy, bleeding, ACLF
Evaluation of the predictive value of the CLIF (Chronic LIver Failure)-C (cirhosis) AD (Decompensation) score in decompensated cirrhotics listed without organ failure	Months 3, Month 6, Month 9, Month 12.	death and drop out

Trial Locations

Locations (1)

Pr Duvoux; 🇫🇷 Créteil, France