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

Last updated: February 16, 2011
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Completed

Phase

3

Condition

Hepatitis

Liver Failure

Liver Disease

Treatment

N/A

Clinical Study ID

NCT00224705
P030423
  • Ages 18-70
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with severe or sub-severe hepatitis, with an indication or a contraindicationto liver transplantation

Exclusion

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 theinotrope

  • 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 hepaticevolutionary, 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

Study Design

Total Participants: 110
Study Start date:
August 01, 2004
Estimated Completion Date:
January 31, 2009

Study 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).

Connect with a study center

  • Hôpital Paul Brousse

    Villejuif, 94800
    France

    Site Not Available

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