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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2009-01-31

Brief Summary

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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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Detailed Description

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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).

Conditions

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Hepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Molecular Adsorbent Recirculating System (MARS®)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No