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

Primary Purpose

Hepatitis

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Molecular Adsorbent Recirculating System (MARS®)

About this trial

This is an interventional treatment trial for Hepatitis focused on measuring Albumin dialysis, MARS system, Extracorporeal artificial liver support, Fulminant hepatitis, Subfulminant hepatitis, Acute liver failure

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hôpital Paul Brousse

Outcomes

Primary Outcome Measures

Patient survival at six months

Secondary Outcome Measures

Patient survival at six months without neurological sequelae

Patient survival at 1 year

Graft survival at six months and 1 year

Number of patients who improve their liver function and no longer need a transplant in each stage of the trial

Hospital mortality before the transplant

Evaluation, at different stages, of the progression of the neurological condition (clinical and electroencephalographic stages, Glasgow scale)

Evaluation at different stages, of the progression of biological parameters, which reflect liver and kidney function

Evaluation of the safety parameters of the MARS® system (thromboembolism, risk of haemorrhage and infections)

Economic elements: duration of stay in the Intensive Care Unit (ICU) up to the transplant and after the transplant

duration of hospitalisation

Full Information

NCT ID

NCT00224705

First Posted

September 19, 2005

Last Updated

February 16, 2011

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT00224705

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2007

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

Yes

5. 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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis

Keywords

Albumin dialysis, MARS system, Extracorporeal artificial liver support, Fulminant hepatitis, Subfulminant hepatitis, Acute liver failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Molecular Adsorbent Recirculating System (MARS®)

Primary Outcome Measure Information:

Title

Patient survival at six months

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Patient survival at six months without neurological sequelae

Time Frame

6 months

Title

Patient survival at 1 year

Time Frame

during one year

Title

Graft survival at six months and 1 year

Time Frame

at 6 months and at one year

Title

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

Title

Hospital mortality before the transplant

Time Frame

during one year

Title

Evaluation, at different stages, of the progression of the neurological condition (clinical and electroencephalographic stages, Glasgow scale)

Time Frame

during one year

Title

Evaluation at different stages, of the progression of biological parameters, which reflect liver and kidney function

Time Frame

during one year

Title

Evaluation of the safety parameters of the MARS® system (thromboembolism, risk of haemorrhage and infections)

Time Frame

during one year

Title

Economic elements: duration of stay in the Intensive Care Unit (ICU) up to the transplant and after the transplant

Time Frame

during one year

Title

duration of hospitalisation

Time Frame

during one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Faouzi SALIBA, Pr, MD, PhD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Paul Brousse

City

Villejuif

ZIP/Postal Code

94800

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

12950955

Citation

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. doi: 10.1034/j.1478-3231.23.s.3.4.x.

Results Reference

background

PubMed Identifier

24126646

Citation

Saliba F, Camus C, Durand F, Mathurin P, Letierce A, Delafosse B, Barange K, Perrigault PF, Belnard M, Ichai P, Samuel D. Albumin dialysis with a noncell artificial liver support device in patients with acute liver failure: a randomized, controlled trial. Ann Intern Med. 2013 Oct 15;159(8):522-31. doi: 10.7326/0003-4819-159-8-201310150-00005.

Results Reference

derived

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

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