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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00224705
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : February 17, 2011
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

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 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

Condition or disease Intervention/treatment Phase
Hepatitis Device: Molecular Adsorbent Recirculating System (MARS®) Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of the Albumin Dialysis MARS® Therapy in Patients With Fulminant and Subfulminant Hepatic Failure
Study Start Date : August 2004
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis




Primary Outcome Measures :
  1. Patient survival at six months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224705


Locations
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France
Hôpital Paul Brousse
Villejuif, France, 94800
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Faouzi SALIBA, Pr, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cecile JOURDAIN, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00224705    
Other Study ID Numbers: P030423
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: February 17, 2011
Last Verified: July 2007
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Albumin dialysis
MARS system
Extracorporeal artificial liver support
Fulminant hepatitis
Subfulminant hepatitis
Acute liver failure
Additional relevant MeSH terms:
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Hepatitis
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases