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

Phase 3

Completed

• Conditions: Hepatitis

• Registration Number: NCT00224705
• Lead Sponsor: 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

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 Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-19
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-23
• Status Verified: 2007-07
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Last Update Submitted: 2011-02-16
• Last Update Posted: 2011-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Patients with severe or sub-severe hepatitis, with an indication or a contraindication to liver transplantation

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient survival at six months	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Paul Brousse; 🇫🇷 Villejuif, France