New Prognostic Predictive Models of Mortality of Decompensated Cirrhotic Patients Waiting for Liver Transplantation (SUPERMELD)
Primary Purpose
Decompensated Cirrhosis, Liver Transplantation
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SuperMELD
Sponsored by
About this trial
This is an interventional other trial for Decompensated Cirrhosis focused on measuring Liver transplantation, Predictive prognostic models, Decompensated cirrhosis
Eligibility 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
Sites / Locations
- Pr DuvouxRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SuperMELD
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Complications predicted by each of the independent predictors
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)
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
Full Information
NCT ID
NCT03820271
First Posted
January 18, 2019
Last Updated
May 2, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03820271
Brief Title
New Prognostic Predictive Models of Mortality of Decompensated Cirrhotic Patients Waiting for Liver Transplantation
Acronym
SUPERMELD
Official Title
Construction of New Predictive Mathematical Models of Mortality in Decompensated Cirrhotic Patients Who Are Candidates for Liver Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompensated Cirrhosis, Liver Transplantation
Keywords
Liver transplantation, Predictive prognostic models, Decompensated cirrhosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SuperMELD
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
SuperMELD
Intervention Description
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 Outcome Measure Information:
Title
predictive value of the new multivariate prognostic models in patients listed for decompensated cirrhosis
Description
Predictive value of mortality and drop out in the waiting list
Time Frame
Month 3.
Secondary Outcome Measure Information:
Title
Individual predictive value of each of the new candidate predictors
Description
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
Title
Complications predicted by each of the independent predictors
Description
infection, renal dysfunction, encephalopathy, bleeding, ACLF
Time Frame
Month 3 Month 6, Month 9, Month 12.Month 12
Title
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.
Title
Evaluation of the predictive value of the CLIF (Chronic LIver Failure)-C (cirhosis) AD (Decompensation) score in decompensated cirrhotics listed without organ failure
Description
death and drop out
Time Frame
Months 3, Month 6, Month 9, Month 12.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe Duvoux, PHD
Phone
01 49 81 43 28
Ext
+33
Email
christophe.duvoux@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candy Estevez
Organizational Affiliation
APHP DRCI
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Laetitia Gregoire
Organizational Affiliation
APHP URC
Official's Role
Study Chair
Facility Information:
Facility Name
Pr Duvoux
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Duvoux, PhD
Phone
0149814328
Ext
+33
Email
christophe.duvoux@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
New Prognostic Predictive Models of Mortality of Decompensated Cirrhotic Patients Waiting for Liver Transplantation
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