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

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ClinicalTrials.gov Identifier: NCT03820271
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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

Condition or disease Intervention/treatment Phase
Decompensated Cirrhosis Liver Transplantation Other: SuperMELD Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Construction of New Predictive Mathematical Models of Mortality in Decompensated Cirrhotic Patients Who Are Candidates for Liver Transplantation
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2022

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Arms and Interventions
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Arm Intervention/treatment
SuperMELD 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820271


Contacts
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Contact: Christophe Duvoux, PHD 01 49 81 43 28 ext +33 christophe.duvoux@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Chair: Candy Estevez APHP DRCI
Study Chair: Laetitia Gregoire APHP URC
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03820271    
Other Study ID Numbers: K170914J
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Liver transplantation
Predictive prognostic models
Decompensated cirrhosis
Additional relevant MeSH terms:
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Fibrosis
Pathologic Processes