CClinicalTrials.gg
CompletedNCT03820271SUPERMELDUpdated Mar 12, 2026

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

An interventional study of SuperMELD in Decompensated Cirrhosis and Liver Transplantation, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
501
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Decompensated Cirrhosis
  • Liver Transplantation

Keywords

  • Liver transplantation
  • Predictive prognostic models
  • Decompensated cirrhosis
03

In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
501 participants (actual)

Study arms

  • Other
    SuperMELD

    Other: SuperMELD

Interventions

  • OtherSuperMELD

    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.

06

What researchers measure

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

    Time frame: Month 3.

Secondary outcomes

  1. 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.

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

  2. Complications predicted by each of the independent predictors

    infection, renal dysfunction, encephalopathy, bleeding, ACLF

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

  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

    death and drop out

    Time frame: 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)

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

    Time frame: Month 6

07

Study locations

1 site
  • Pr Duvoux
    Créteil, 94000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03820271
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jan 29, 2019
Start date
Oct 2, 2020
Primary completion
Nov 6, 2025
Completion
Nov 11, 2025
Last update
Mar 12, 2026

Study contacts

Candy Estevez
study chair · APHP DRCI
Laetitia Gregoire
study chair · APHP URC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion