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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Hepatitis

Treatments: Device: Molecular Adsorbent Recirculating System (MARS®)

Study type: Interventional

Funder types: Other

Identifiers

NCT00224705

P030423

Details and patient eligibility

About

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

Full 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).

Enrollment: 110 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)