Hepatitis
Conditions
Keywords
Albumin dialysis, MARS system, Extracorporeal artificial liver support, Fulminant hepatitis, Subfulminant hepatitis, Acute liver failure
Brief summary
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: 1. Reducing the number of patients who die before a graft is available 2. Increasing the chances of survival without a liver transplant 3. Reducing the pre- and post-operative mortality in transplant patients
Detailed description
Patients with fulminant or subfulminant hepatitis with either an indication or a relative contraindication to a liver transplantation, are randomized to two groups: 1. 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 2. 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).
Interventions
DEVICEMolecular Adsorbent Recirculating System (MARS®)
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient survival at six months | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Patient survival at six months without neurological sequelae | 6 months |
| 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 |
| Evaluation, at different stages, of the progression of the neurological condition (clinical and electroencephalographic stages, Glasgow scale) | during one year |
Countries
France
Outcome results
None listed