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

Liver Transplantation Clinical Trial

— SUPERMELD  

Official title:

Construction of New Predictive Mathematical Models of Mortality in Decompensated Cirrhotic Patients Who Are Candidates for Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03820271
• Other study ID #: K170914J
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: October 1, 2023

Study information

• Verified date: April 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Christophe Duvoux, PHD
• Phone: 01 49 81 43 28
• Email: christophe.duvoux[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Decompensated Cirrhosis
• Fibrosis
• Liver Transplantation

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Pr Duvoux	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	predictive value of the new multivariate prognostic models in patients listed for decompensated cirrhosis	Predictive value of mortality and drop out in the waiting list	Month 3.
Secondary	Individual predictive value of each of the new candidate predictors	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.	Month 3. Month 6, Month 9, Month 12Month 12
Secondary	Complications predicted by each of the independent predictors	infection, renal dysfunction, encephalopathy, bleeding, ACLF	Month 3 Month 6, Month 9, Month 12.Month 12
Secondary	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.
Secondary	Evaluation of the predictive value of the CLIF (Chronic LIver Failure)-C (cirhosis) AD (Decompensation) score in decompensated cirrhotics listed without organ failure	death and drop out	Months 3, Month 6, Month 9, Month 12.