Primary Outcome Measures:
- Patient survival at six months [ Time Frame: 6 months ]
Secondary Outcome Measures:
- Patient survival at six months without neurological sequelae [ Time Frame: 6 months ]
- Patient survival at 1 year [ Time Frame: during one year ]
- Graft survival at six months and 1 year [ Time Frame: 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 [ Time Frame: during one year ]
- Hospital mortality before the transplant [ Time Frame: during one year ]
- Evaluation, at different stages, of the progression of the neurological condition (clinical and electroencephalographic stages, Glasgow scale) [ Time Frame: during one year ]
- Evaluation at different stages, of the progression of biological parameters, which reflect liver and kidney function [ Time Frame: during one year ]
- Evaluation of the safety parameters of the MARS® system (thromboembolism, risk of haemorrhage and infections) [ Time Frame: during one year ]
- Economic elements: duration of stay in the Intensive Care Unit (ICU) up to the transplant and after the transplant [ Time Frame: during one year ]
- duration of hospitalisation [ Time Frame: during one year ]
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).
Purpose
