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

February 16, 2011 updated by: Assistance Publique - Hôpitaux de Paris

Efficacy and Safety of the Albumin Dialysis MARS® Therapy 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Villejuif, France, 94800
        • Hopital Paul Brousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient survival at six months
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Faouzi SALIBA, Pr, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 23, 2005

Study Record Updates

Last Update Posted (Estimate)

February 17, 2011

Last Update Submitted That Met QC Criteria

February 16, 2011

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P030423

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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