The MARS® Albumin Dialysis System in Patients With Fulminant and Subfulminant Hepatic Failure

Study Overview
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Brief Summary
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The purpose of this study is to improve the survival rate of those patients with acute fulminant hepatitis through treatment with the MARS® extra-corporal liver-purification system by: Reducing the number of patients who die before a graft is available Increasing the chances of survival without a liver transplant Reducing the pre- and post-operative mortality in transplant patients

Detailed Description
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Patients with fulminant or subfulminant hepatitis with either an indication or a relative contraindication to a liver transplantation, are randomized to two groups: A group treated with the conventional medical intensive treatment (including the hemodialysis techniques, continuous veno-venous hemofiltration or hemodiafiltration, if necessary) and the gold standard surgical treatment (liver transplantation) compared to A group receiving, in addition to the conventional medical intensive treatment, albumin dialysis using the MARS device and the gold standard surgical treatment (liver transplantation).

Official Title
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Efficacy and Safety of the Albumin Dialysis MARS® Therapy in Patients With Fulminant and Subfulminant Hepatic Failure

Conditions
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Hepatitis

Intervention / Treatment
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* Device: Molecular Adsorbent Recirculating System (MARS®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with severe or sub-severe hepatitis, with an indication or a contraindication to liver transplantation Exclusion Criteria: Sepsis severe not controlled Haemorrhage activates not controlled Clinical Obviousness of disseminated intravascular coagulation Severe Pathology cardiopulmonary (NYHA > or = 2) Pregnancy, breast feeding Average blood Pressure < 40 mmHg more than 10 minutes in spite of a support by the inotrope Nonhepatic coma of origin Cholestases extra-hepatitic Antecedents of heavy surgery in the 4 previous weeks or surgical problems unsolved Absolute counter-indication with hepatic transplantation (extra Neoplasia hepatic evolutionary, irreversible cerebral Attack, irreversible multi-visceral Failure, visceral tares contra-indicating the transplantation) Positive serology HIV Hepatic Demonstrations of the malignant hemopathies Participation in another therapeutic test in the 4 previous weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Molecular Adsorbent Recirculating System (MARS®)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survival at six months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survival at six months without neurological sequelae |  | 6 months | 
| Patient survival at 1 year |  | during one year | 
| Graft survival at six months and 1 year |  | at 6 months and at one year | 
| Number of patients who improve their liver function and no longer need a transplant in each stage of the trial |  | during one year | 
| Hospital mortality before the transplant |  | during one year | 
| Evaluation, at different stages, of the progression of the neurological condition (clinical and electroencephalographic stages, Glasgow scale) |  | during one year | 
| Evaluation at different stages, of the progression of biological parameters, which reflect liver and kidney function |  | during one year | 
| Evaluation of the safety parameters of the MARS® system (thromboembolism, risk of haemorrhage and infections) |  | during one year | 
| Economic elements: duration of stay in the Intensive Care Unit (ICU) up to the transplant and after the transplant |  | during one year | 
| duration of hospitalisation |  | during one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Albumin dialysis, MARS system, Extracorporeal artificial liver support, Fulminant hepatitis, Subfulminant hepatitis, Acute liver failure