NCT00224705

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hepatitis

Interventions

Type	Name	Description
DEVICE	Molecular Adsorbent Recirculating System (MARS®)

Timeline

• Start date: 2004-08-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2005-09-23
• Last updated: 2011-02-17

Locations

1 site across 1 country: France