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

Assistance Publique - Hôpitaux de Paris110 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Hepatitis

Interventions

Molecular Adsorbent Recirculating System (MARS®)DEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Paul Brousse

Villejuif, France

Outcomes

Primary Outcomes

Patient survival at six months

Time frame: 6 months

Secondary Outcomes

Patient survival at six months without neurological sequelae

Time frame: 6 months

Patient survival at 1 year

Time frame: during one year

Graft survival at six months and 1 year

Time frame: 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

Time frame: during one year

Hospital mortality before the transplant

Time frame: during one year

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

Time frame: during one year

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

Time frame: during one year

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

Time frame: during one year

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

Time frame: during one year

Data from ClinicalTrials.gov

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