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

Hepatitis Clinical Trial

Official title:

Efficacy and Safety of the Albumin Dialysis MARS® Therapy in Patients With Fulminant and Subfulminant Hepatic Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224705
• Other study ID #: P030423
• Status: Completed
• Phase: Phase 3
• First received: September 19, 2005
• Last updated: February 16, 2011
• Start date: August 2004
• Est. completion date: January 2009

Study information

• Verified date: July 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Liver Failure

Intervention

Device:
• Molecular Adsorbent Recirculating System (MARS®)

Locations

Country	Name	City	State
France	Hôpital Paul Brousse	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Novelli G, Rossi M, Pretagostini R, Novelli L, Poli L, Ferretti G, Iappelli M, Berloco P, Cortesini R. A 3-year experience with Molecular Adsorbent Recirculating System (MARS): our results on 63 patients with hepatic failure and color Doppler US evaluation of cerebral perfusion. Liver Int. 2003;23 Suppl 3:10-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient survival at six months		6 months	Yes
Secondary	Patient survival at six months without neurological sequelae		6 months	Yes
Secondary	Patient survival at 1 year		during one year	Yes
Secondary	Graft survival at six months and 1 year		at 6 months and at one year	Yes
Secondary	Number of patients who improve their liver function and no longer need a transplant in each stage of the trial		during one year	Yes
Secondary	Hospital mortality before the transplant		during one year	Yes
Secondary	Evaluation, at different stages, of the progression of the neurological condition (clinical and electroencephalographic stages, Glasgow scale)		during one year	Yes
Secondary	Evaluation at different stages, of the progression of biological parameters, which reflect liver and kidney function		during one year	Yes
Secondary	Evaluation of the safety parameters of the MARS® system (thromboembolism, risk of haemorrhage and infections)		during one year	Yes
Secondary	Economic elements: duration of stay in the Intensive Care Unit (ICU) up to the transplant and after the transplant		during one year	Yes
Secondary	duration of hospitalisation		during one year	Yes