Status:
COMPLETED
The MARS® Albumin Dialysis System in Patients With Fulminant and Subfulminant Hepatic Failure
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Hepatitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 th...
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 conven...
Eligibility Criteria
Inclusion
- Patients with severe or sub-severe hepatitis, with an indication or a contraindication to liver transplantation
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00224705
Start Date
August 1 2004
End Date
January 1 2009
Last Update
February 17 2011
Active Locations (1)
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1
Hôpital Paul Brousse
Villejuif, France, 94800