Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 18, 2019
First Posted Date  ICMJE January 29, 2019
Last Update Posted Date August 6, 2019
Estimated Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
  • 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.
  • 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
  • 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. ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE New Prognostic Predictive Models of Mortality of Decompensated Cirrhotic Patients Waiting for Liver Transplantation
Official Title  ICMJE Construction of New Predictive Mathematical Models of Mortality in Decompensated Cirrhotic Patients Who Are Candidates for Liver Transplantation
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Decompensated Cirrhosis
  • Liver Transplantation
Intervention  ICMJE 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.

Study Arms  ICMJE SuperMELD
Intervention: Other: SuperMELD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2019)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2022
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christophe Duvoux, PHD 01 49 81 43 28 ext +33 christophe.duvoux@aphp.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03820271
Other Study ID Numbers  ICMJE K170914J
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Candy Estevez APHP DRCI
Study Chair: Laetitia Gregoire APHP URC
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP