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Completed

NCT Number: NCT00224705

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

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

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Key information

Conditions

Hepatitis Chemical and Drug Induced Liver Injury Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute Massive Hepatic Necrosis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Paul Brousse

Villejuif, 94800, France

About this study

Patients with fulminant or subfulminant hepatitis with either an indication or a relative contraindication to a liver transplantation, are randomized to two groups:

  • 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
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Molecular Adsorbent Recirculating System (MARS®)

Device

Primary outcomes

  1. Patient survival at six months

    Time frame: 6 months

Secondary outcomes

  1. Patient survival at six months without neurological sequelae

    Time frame: 6 months

  2. Patient survival at 1 year

    Time frame: during one year

  3. Graft survival at six months and 1 year

    Time frame: at 6 months and at one year

  4. Number of patients who improve their liver function and no longer need a transplant in each stage of the trial

    Time frame: during one year

  5. Hospital mortality before the transplant

    Time frame: during one year

  6. Evaluation, at different stages, of the progression of the neurological condition (clinical and electroencephalographic stages, Glasgow scale)

    Time frame: during one year

  7. Evaluation at different stages, of the progression of biological parameters, which reflect liver and kidney function

    Time frame: during one year

  8. Evaluation of the safety parameters of the MARS® system (thromboembolism, risk of haemorrhage and infections)

    Time frame: during one year

  9. Economic elements: duration of stay in the Intensive Care Unit (ICU) up to the transplant and after the transplant

    Time frame: during one year

  10. duration of hospitalisation

    Time frame: during one year

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 23, 2005
Registry last updated
Feb 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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