Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SuperMELD | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SuperMELD | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Month 3. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 3. Month 6, Month 9, Month 12Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Month 6 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Candy Estevez | APHP DRCI | Study Chair |
| Laetitia Gregoire | APHP URC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pr Duvoux | Créteil | 94000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| Complications predicted by each of the independent predictors | infection, renal dysfunction, encephalopathy, bleeding, ACLF | Month 3 Month 6, Month 9, Month 12.Month 12 |
| Added predictive value for mortality and drop out of new multivariate prognostic models on MELD (model end stage for liver disease) | 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 | death and drop out | Months 3, Month 6, Month 9, Month 12. |