Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)
NCT00287235 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2025-03-03
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
Interventions
- DEVICE
-
MARS
- DRUG
-
Standard Medical Therapy
Sponsors & Collaborators
-
Gambro Renal Products, Inc.
collaborator INDUSTRY -
Baxter Healthcare Corporation
collaborator INDUSTRY -
Vantive Health LLC
lead INDUSTRY
Principal Investigators
-
Tarek Hassanein, MD · University of California San Diego Medical Center (UCSD)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-09-30
- Primary Completion
- 2003-11-30
- Completion
- 2004-04-30
Countries
- United States
- Belgium
- Denmark
Study Locations
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