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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00224705

Collaborator

(none)

110

Enrollment

Location

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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:

Reducing the number of patients who die before a graft is available
Increasing the chances of survival without a liver transplant
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:

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).

Study Design

Study Type:

Interventional

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 :

Aug 1, 2004

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Jan 1, 2009

Outcome Measures

Primary Outcome Measures

Patient survival at six months [6 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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