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Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00287235
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : April 5, 2017
Gambro Renal Products, Inc.
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Brief Summary:
The primary objective of the study was to compare the efficacy, safety and tolerability of Extracorporeal Albumin Dialysis (ECAD) using the Molecular Adsorbent Recirculating System (MARS®) device in improving severe HE by 2 grades compared to Standard Medical Therapy (SMT) in patients with chronic End Stage Liver Disease (ESLD) during a 5 day study period.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Liver Failure Hepatitis, Chronic Liver Cirrhosis Device: MARS Drug: Standard Medical Therapy Not Applicable

Detailed Description:
The trial was a two-group unblinded multicenter clinical trial. Patients were randomized to receive either SMT or SMT plus five days MARS® treatment. The trial design called for patients to receive a baseline hepatic encephalopathy (HE) assessment on admission, and at 12-hour intervals, giving 10 HE measurements during treatment using a refinement / adaptation of the Conn West Haven HE Criteria HE scoring system

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Controlled Study Of The Clinical Efficacy Of Albumin Dialysis Using The Molecular Adsorbent Recirculating System (MARS®) For The Treatment Of Patients With Hepatic Encephalopathy
Study Start Date : September 2000
Actual Primary Completion Date : November 2003
Actual Study Completion Date : April 2004

Arm Intervention/treatment
Experimental: Group 1: Standard Medical Therapy + MARS
Patients who were randomized to Group 1 received daily MARS treatments in addition to Standard Medical Therapy for 5 consecutive days.
Device: MARS
Other Names:
  • ECAD
  • Extracorporeal Albumin Dialysis

Drug: Standard Medical Therapy
Other Name: SMT

Active Comparator: Group 2: Standard Medical Therapy Only
Patients who were randomized to Group 2 received standard medical treatment only.
Drug: Standard Medical Therapy
Other Name: SMT

Primary Outcome Measures :
  1. Two-point reduction in HE score from the randomization grade [ Time Frame: Within the five-day treatment period ]
    The primary outcome measure was a two-point reduction in HE score from the the randomization grade (i.e. Grade 4 improved to at least Grade 2 and Grade 3 improved to at least Grade 1). Two summary statistics were used in the analysis: 1) The proportion of HE readings within the five-day treatment period showing an improvement of at least two points over baseline 2) The time from admission to the first two-point improvement in HE score.

Secondary Outcome Measures :
  1. Magnitude, duration and time of improvement in Hepatic Encephalopathy [ Time Frame: Within the five-day treatment period ]
  2. Cognitive function and functional status of patients [ Time Frame: Within the five-day treatment period ]
  3. Renal function, serum bilirubin, bile acids, prothrombin activity and the hemodynamics of patients with Hepatic Encephalopathy [ Time Frame: Within the five-day treatment period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Signed written informed consent by patient or patient's legally appointed representative
  2. Be at least 18 years of age; male or female
  3. Have chronic end stage liver disease with worsening Hepatic Encephalopathy (Grades 3,4).

Exclusion Criteria:

  1. Clinically significant bleeding from gastrointestinal or other site within the last 24 hours and requires 2 or more units of blood to maintain a stable hemoglobin level
  2. Hemodynamically unstable or on vasopressor agents for blood pressure support (except for renal-dosed dopamine)
  3. On acute or chronic hemodialysis or continuous renal replacement therapy (CRRT)
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00287235

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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, California
University of California, San Diego
San Diego, California, United States, 92103-8707
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
Columbia-Presbyterian Medical Center
New York, New York, United States, 10032
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
UZ Gasthuisberg
Leuven, Belgium
University Hospital of Copenhagen, Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Baxter Healthcare Corporation
Gambro Renal Products, Inc.
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Principal Investigator: Tarek Hassanein, MD University of California San Diego Medical Center (UCSD)
Publications of Results:
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Responsible Party: Baxter Healthcare Corporation Identifier: NCT00287235    
Other Study ID Numbers: MARS HE Study
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Keywords provided by Baxter Healthcare Corporation:
Hepatic Encephalopathy
End Stage Liver Disease
Albumin Dialysis
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Failure
Hepatic Encephalopathy
Hepatitis, Chronic
Brain Diseases
Liver Diseases
Digestive System Diseases
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases