Molecular Adsorbent Recirculating System (MARS) for Patients With Cirrhosis and Hepatic Encephalopathy

This study has been completed.
Sponsor:
Collaborator:
Sponsor of study was Teraklin, AG and Gambro, Inc.
Information provided by (Responsible Party):
Tarek Hassanein, SCTI Research Foundation
ClinicalTrials.gov Identifier:
NCT00287235
First received: February 2, 2006
Last updated: June 11, 2012
Last verified: June 2012
  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 3

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

Resource links provided by NLM:


Further study details as provided by SCTI Research Foundation:

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:

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

Exclusion Criteria:

  1. 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
  2. Hemodynamically unstable or on vasopressor agents for blood pressure support more than 3 ug dopamine /min/kg body weight.
  3. On acute or chronic hemodialysis or continuous renal replacement therapy (CRRT) at the time of randomization
  4. Pregnancy
  5. Inability to obtain informed consent
  6. Uncontrolled sepsis as defined by hemodynamic instability
  7. Post-liver transplant
  8. Fulminant hepatic failure
  9. Irreversible brain damage as indicated by the neurologic examination and CT imaging
  10. Endocarditis
  11. Pulmonary edema
  12. Massive aspiration pneumonia secondary to Hepatic Encephalopathy
  13. Active alcohol consumption as determined by a positive blood ethanol level on enrollment/admission
  14. 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
Tarek Hassanein
Sponsor of study was Teraklin, AG and Gambro, Inc.
  More Information

Publications:
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.

Responsible Party: Tarek Hassanein, Medical Director, SCTI Research Foundation
ClinicalTrials.gov Identifier: NCT00287235     History of Changes
Other Study ID Numbers: MARS HE Study
Study First Received: February 2, 2006
Last Updated: June 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by SCTI Research Foundation:
Hepatic Encephalopathy
End Stage Liver Disease
Cirrhosis
MARS
Albumin Dialysis

Additional relevant MeSH terms:
Hepatic Encephalopathy
Hepatitis
Hepatitis A
Hepatitis, Chronic
Liver Cirrhosis
Fibrosis
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders

ClinicalTrials.gov processed this record on April 16, 2014