Clinical trial NCT03820271: New Prognostic Predictive Models of Mortality of Decompensated Cirrhotic Patients Waiting for Liver Transplantation
Official title: Construction of New Predictive Mathematical Models of Mortality in Decompensated Cirrhotic Patients Who Are Candidates for Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Decompensated Cirrhosis
Liver Transplantation
Keywords: Liver transplantation
Predictive prognostic models
Decompensated cirrhosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The pre-inclusion visit will be between 1 week and at the latest 2 days before the inclusion visit. The duration of the inclusion period is 24 months. After inclusion, samples at D5, D10 and D14 (additional samples) for sequential analysis of CRP and ammonemia and simple clinical reassessment will be scheduled for the period of hospitalization or routine consultations. Subsequent scheduled visits will take place quarterly until the transplant. Comprehensive nutritional , frailty and CT assessment of sarcopenia (psoas) by abdominal CT without contrast injection will be performed at 6 months as part of the protocol. Additional visits will be scheduled as part of the usual patient follow-up.
Primary purpose: OTHER

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


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

Primary outcomes:
measure: predictive value of the new multivariate prognostic models in patients listed for decompensated cirrhosis
timeFrame: Month 3.
Secondary outcomes:
measure: Individual predictive value of each of the new candidate predictors
timeFrame: Month 3. Month 6, Month 9, Month 12Month 12
measure: Complications predicted by each of the independent predictors
timeFrame: Month 3 Month 6, Month 9, Month 12.Month 12
measure: Added predictive value for mortality and drop out of new multivariate prognostic models on MELD (model end stage for liver disease)
timeFrame: Months 3, Month 6, Month 9, Month 12.
measure: Evaluation of the predictive value of the CLIF (Chronic LIver Failure)-C (cirhosis) AD (Decompensation) score in decompensated cirrhotics listed without organ failure
timeFrame: Months 3, Month 6, Month 9, Month 12.
Other outcomes:
Locations:
city: Créteil
country: France
facility: Pr Duvoux
Study officials:
affiliation: APHP DRCI
name: Candy Estevez
role: STUDY_CHAIR
affiliation: APHP URC
name: Laetitia Gregoire
role: STUDY_CHAIR
References: