Molecular Adsorbent Recirculating System (MARS) for Patients With Cirrhosis and Hepatic Encephalopathy - Full Text View

Sponsors and Collaborators:	University of California, San Diego Sponsor of study was Teraklin, AG and Gambro, Inc.
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00287235

Purpose

This purpose of this study is to determine the safety and efficacy of albumin dialysis using the MARS device in improving severe Hepatic Encephalopathy compared to standard medical therapy in patients with chornic ESLD.

Condition	Intervention	Phase
Hepatic Encephalopathy Liver Failure Hepatitis, Chronic Liver Cirrhosis	Device: Molecular Adsorent Recirculating System (MARS)	Phase III

MedlinePlus related topics: Cirrhosis Hepatitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Controlled Study Evaluating Extracorporeal Albumin Dialysis Using the Molecular Adsorbent Recirculating System (MARS) for Patients With Cirrhosis and Hepatic Encephalopathy

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

The primary objective of the study was to compare the efficacy, safety and tolerability of ECAD using the MARS device in improving severe HE by 2 grades compared to standard medical therapy in patients with chronic ESLD during the 5 day study period.

Secondary Outcome Measures:

The secondary objectives were to assess the time to improvement of HE by 2 grades and the effects of ECAD on laboratory parameters.

Estimated Enrollment:	70
Study Start Date:	August 2000
Estimated Study Completion Date:	April 2004

Detailed Description:

The primary objective of the study was to compare the efficacy, safety and tolerability of ECAD using the MARS device in improving severe HE by 2 grades compared to standard medical therapy in patients with chronic ESLD during the 5 day study period. The secondary objectives were to assess the time to improvement of HE by 2 grades and the effects of ECAD on laboratory parameters.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with cirrhosis and hepatic encephalopathy grades 3 and 4
At least 18 years old
Signed consent of legally appointed representatives

Exclusion Criteria:

Clinically significant bleeding from gastrointestinal or other site within the last 24 hours which required 2 or more units of blood to maintain a stable hemoglobin level
Hemodynamically unstable or on vasopressor agents for blood pressure support more than 3 ug dopamine /min/kg body weight.
On acute or chronic hemodialysis or continuous renal replacement therapy (CRRT) at the time of randomization
Pregnancy
Inability to obtain informed consent
Uncontrolled sepsis as defined by hemodynamic instability
Post-liver transplant
Fulminant hepatic failure
Irreversible brain damage as indicated by the neurologic examination and CT imaging
Endocarditis
Pulmonary edema
Massive aspiration pneumonia secondary to Hepatic Encephalopathy
Active alcohol consumption as determined by a positive blood ethanol level on enrollment/admission
Acute main portal vein thrombosis in patients with Hepatocellular Carcinoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287235

Locations

United States, Alabama
University of Alabama
Birmingham, Alabama, United States
United States, California
University of California, San Diego
San Diego, California, United States, 92103-8707
United States, Illinois
Northwestern University
Chicago, Illinois, United States
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States
United States, New York
Columbia University
New York, New York, United States
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States
Belgium
UZ Gasthuisberg
Leuven, Belgium
Denmark
Rigshospitalet Copenhagen
Copenhagen, Denmark

Sponsors and Collaborators

University of California, San Diego

Sponsor of study was Teraklin, AG and Gambro, Inc.

More Information

Publications of Results:

Hassanein T, Tofteng F, Brown R, Mc Guire B, Lynch P, Mehta R, Larsen F, Gornbein J, Stange J, Blei A. Efficacy of Albumin Dialysis (MARS) in Patients with Cirrhosis and Advanced Grades of Hepatic Encephalopathy: A Prospective, Controlled, Randomized Multicenter Trial. Hepatology 2004;40:726A.

Study ID Numbers:	MARS HE Study
Study First Received:	February 2, 2006
Last Updated:	February 2, 2006
ClinicalTrials.gov Identifier:	NCT00287235
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, San Diego:

Hepatic Encephalopathy
End Stage Liver Disease
Cirrhosis
MARS
Albumin Dialysis

Study placed in the following topic categories:

Liver Diseases
Neurotoxicity Syndromes
Hepatitis, Chronic
Fibrosis
Brain Damage, Chronic
Disorders of Environmental Origin
Liver Cirrhosis
Brain Diseases
Signs and Symptoms
Mental Disorders
Brain Injuries
Dementia
Neurobehavioral Manifestations
Hepatic Insufficiency
Delirium

Liver Failure
Metabolic Diseases
Neurotoxicity syndromes
Poisoning
Central Nervous System Diseases
Confusion
Encephalitis
Cognition Disorders
Virus Diseases
Hepatitis
Hepatic Encephalopathy
Digestive System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Central Nervous System Infections
Neurologic Manifestations

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases
Central Nervous System Viral Diseases

ClinicalTrials.gov processed this record on February 12, 2009