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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00224705
First received: September 19, 2005
Last updated: February 16, 2011
Last verified: July 2007
History of Changes
  Purpose

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 Intervention Phase
Hepatitis
 Device: Molecular Adsorbent Recirculating System (MARS®)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of the Albumin Dialysis MARS® Therapy in Patients With Fulminant and Subfulminant Hepatic Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Patient survival at six months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Patient survival at six months without neurological sequelae [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Patient survival at 1 year [ Time Frame: during one year ] [ Designated as safety issue: Yes ]
  • Graft survival at six months and 1 year [ Time Frame: at 6 months and at one year ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Hospital mortality before the transplant [ Time Frame: during one year ] [ Designated as safety issue: Yes ]
  • Evaluation, at different stages, of the progression of the neurological condition (clinical and electroencephalographic stages, Glasgow scale) [ Time Frame: during one year ] [ Designated as safety issue: Yes ]
  • Evaluation at different stages, of the progression of biological parameters, which reflect liver and kidney function [ Time Frame: during one year ] [ Designated as safety issue: Yes ]
  • Evaluation of the safety parameters of the MARS® system (thromboembolism, risk of haemorrhage and infections) [ Time Frame: during one year ] [ Designated as safety issue: Yes ]
  • Economic elements: duration of stay in the Intensive Care Unit (ICU) up to the transplant and after the transplant [ Time Frame: during one year ] [ Designated as safety issue: Yes ]
  • duration of hospitalisation [ Time Frame: during one year ] [ Designated as safety issue: Yes ]

Enrollment: 110
Study Start Date: August 2004
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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).
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224705

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

Publications:

Responsible Party: Cecile JOURDAIN, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00224705     History of Changes
Other Study ID Numbers: P030423
Study First Received: September 19, 2005
Last Updated: February 16, 2011
Health Authority: France: Ministry of Health

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:
Hepatitis
Hepatitis A
Liver Failure
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepatic Insufficiency

ClinicalTrials.gov processed this record on May 16, 2013