Clinical trial NCT00224705: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis
Keywords: Albumin dialysis
MARS system
Extracorporeal artificial liver support
Fulminant hepatitis
Subfulminant hepatitis
Acute liver failure
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-09-23
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Patient survival at six months
timeFrame: 6 months
Secondary outcomes:
measure: Patient survival at six months without neurological sequelae
timeFrame: 6 months
measure: Patient survival at 1 year
timeFrame: during one year
measure: Graft survival at six months and 1 year
timeFrame: at 6 months and at one year
measure: Number of patients who improve their liver function and no longer need a transplant in each stage of the trial
timeFrame: during one year
measure: Hospital mortality before the transplant
timeFrame: during one year
measure: Evaluation, at different stages, of the progression of the neurological condition (clinical and electroencephalographic stages, Glasgow scale)
timeFrame: during one year
measure: Evaluation at different stages, of the progression of biological parameters, which reflect liver and kidney function
timeFrame: during one year
measure: Evaluation of the safety parameters of the MARS® system (thromboembolism, risk of haemorrhage and infections)
timeFrame: during one year
measure: Economic elements: duration of stay in the Intensive Care Unit (ICU) up to the transplant and after the transplant
timeFrame: during one year
measure: duration of hospitalisation
timeFrame: during one year
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Hôpital Paul Brousse
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Faouzi SALIBA, Pr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.