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

NCT03820271 | Completed

• 1 other identifier: K170914J
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 1

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
• 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.

Conditions

Decompensated Cirrhosis; Liver Transplantation

Keywords

Liver transplantation; Predictive prognostic models; Decompensated cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Individual predictive value of each of the new candidate predictors

  Month 3. Month 6, Month 9, Month 12Month 12

• Complications predicted by each of the independent predictors

  Month 3 Month 6, Month 9, Month 12.Month 12

• 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.

• 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.

Other Outcomes (1)

• Evaluation of the value of plasma miRNAs to predict 6-month mortality on the liver transplant waiting list or dropout from the list due to worsening condition (Primary Outcome Measure for mirMELD ancillary study)

  Month 6

Study Arms (1)

SuperMELD

OTHER

Other: SuperMELD

Interventions

SuperMELD OTHER

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.

SuperMELD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients enrolled with decompensated cirrhosis associated with hepatocellular carcinoma \>TNM1
• 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
• Patient candidate for a combined transplantation
• Patient with history of organ transplantation (liver, kidney, heart)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pr Duvoux

Créteil, 94000, France

Location

Study Officials

• Candy Estevez

  APHP DRCI

  STUDY CHAIR

• Laetitia Gregoire

  APHP URC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 29, 2019
• Study Start: October 2, 2020
• Primary Completion: November 6, 2025
• Study Completion: November 11, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)