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 : Recruiting
First Posted : January 29, 2019
Last Update Posted : December 16, 2020
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|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)|
|Official Title:||Construction of New Predictive Mathematical Models of Mortality in Decompensated Cirrhotic Patients Who Are Candidates for Liver Transplantation|
|Actual Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||October 1, 2022|
|Estimated Study Completion Date :||October 1, 2023|
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.
- 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
- 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
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
|Contact: Christophe Duvoux, PHD||01 49 81 43 28 ext +firstname.lastname@example.org|
|Créteil, France, 94000|
|Contact: Christophe Duvoux, PhD 0149814328 ext +33 email@example.com|
|Study Chair:||Candy Estevez||APHP DRCI|
|Study Chair:||Laetitia Gregoire||APHP URC|