CompletedPhase 3

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

France110 participantsStarted 2004-08

Plain-language 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

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Patient survival at six months

Timeframe: 6 months

Trial details

NCT IDNCT00224705

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-01