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

NCT00287235 | Completed DMC

• 1 other identifier: MARS HE Study
• Study Type: interventional
• Target: 70
• Locations: 3 countries
• Sites: 8

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.

Conditions

Hepatic Encephalopathy; Liver Failure; Hepatitis, Chronic; Liver Cirrhosis

Keywords

Hepatic Encephalopathy; End Stage Liver Disease; Cirrhosis; MARS; Albumin Dialysis

Outcome Measures

Primary Outcomes (1)

• Two-point reduction in HE score from the randomization grade

  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.

  Within the five-day treatment period

Secondary Outcomes (3)

• Magnitude, duration and time of improvement in Hepatic Encephalopathy

  Within the five-day treatment period

• Cognitive function and functional status of patients

  Within the five-day treatment period

• Renal function, serum bilirubin, bile acids, prothrombin activity and the hemodynamics of patients with Hepatic Encephalopathy

  Within the five-day treatment period

Study Arms (2)

Group 1: Standard Medical Therapy + MARS

EXPERIMENTAL

Patients who were randomized to Group 1 received daily MARS treatments in addition to Standard Medical Therapy for 5 consecutive days.

Device: MARS; Drug: Standard Medical Therapy

Group 2: Standard Medical Therapy Only

ACTIVE COMPARATOR

Patients who were randomized to Group 2 received standard medical treatment only.

Drug: Standard Medical Therapy

Interventions

MARS DEVICE

Also known as: ECAD, Extracorporeal Albumin Dialysis

Group 1: Standard Medical Therapy + MARS

Standard Medical Therapy DRUG

Also known as: SMT

Group 1: Standard Medical Therapy + MARS; Group 2: Standard Medical Therapy Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Hemodynamically unstable or on vasopressor agents for blood pressure support (except for renal-dosed dopamine)
• On acute or chronic hemodialysis or continuous renal replacement therapy (CRRT)
• 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

Sponsors & Collaborators

• Vantive Health LLC: lead
• Gambro Renal Products, Inc.: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (8)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

University of California, San Diego

San Diego, California, 92103-8707, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Columbia-Presbyterian Medical Center

New York, New York, 10032, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

UZ Gasthuisberg

Leuven, Belgium

Location

University Hospital of Copenhagen, Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (1)

• Hassanein TI, Tofteng F, Brown RS Jr, McGuire B, Lynch P, Mehta R, Larsen FS, Gornbein J, Stange J, Blei AT. Randomized controlled study of extracorporeal albumin dialysis for hepatic encephalopathy in advanced cirrhosis. Hepatology. 2007 Dec;46(6):1853-62. doi: 10.1002/hep.21930.

  PMID: 17975845 RESULT

MeSH Terms

Conditions

Hepatic Encephalopathy; Liver Failure; Hepatitis, Chronic; Liver Cirrhosis; End Stage Liver Disease; Fibrosis

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Hepatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tarek Hassanein, MD

  University of California San Diego Medical Center (UCSD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2006
• First Posted: February 6, 2006
• Study Start: September 1, 2000
• Primary Completion: November 1, 2003
• Study Completion: April 1, 2004
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

BE (1); US (6); DK (1)