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Completed

NCT Number: NCT03820271

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pr Duvoux

Créteil, 94000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥18 years old) registered on national waiting list with main diagnosis "cirrhosis" within 14 days (+/-2) before or 7 days (+/-2) after the inclusion in the protocol (using the date of biobank sampling as Day 0)
  • 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 >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)

Treatment and study plan

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.

Primary outcomes

  1. predictive value of the new multivariate prognostic models in patients listed for decompensated cirrhosis

    Time frame: Month 3.

    Predictive value of mortality and drop out in the waiting list

Secondary outcomes

  1. Individual predictive value of each of the new candidate predictors

    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.

  2. Complications predicted by each of the independent predictors

    Time frame: Month 3 Month 6, Month 9, Month 12.Month 12

    infection, renal dysfunction, encephalopathy, bleeding, ACLF

  3. Added predictive value for mortality and drop out of new multivariate prognostic models on MELD (model end stage for liver disease)

    Time frame: Months 3, Month 6, Month 9, Month 12.

  4. Evaluation of the predictive value of the CLIF (Chronic LIver Failure)-C (cirhosis) AD (Decompensation) score in decompensated cirrhotics listed without organ failure

    Time frame: Months 3, Month 6, Month 9, Month 12.

    death and drop out

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)

    Time frame: Month 6

    Identification of microRNA signatures with independent predictive value of MELD for mortality/drop out from the waitlist

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: SUPERMELD

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2019
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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