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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
University of Alabama
Birmingham, Alabama, United States
University of California, San Diego
San Diego, California, United States
Northwestern University
Chicago, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
Columbia-Presbyterian Medical Center
New York, New York, United States
University of Virginia
Charlottesville, Virginia, United States
UZ Gasthuisberg
Leuven, Belgium
University Hospital of Copenhagen, Rigshospitalet
Copenhagen, Denmark
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.
Time frame: Within the five-day treatment period
Magnitude, duration and time of improvement in Hepatic Encephalopathy
Time frame: Within the five-day treatment period
Cognitive function and functional status of patients
Time frame: Within the five-day treatment period
Renal function, serum bilirubin, bile acids, prothrombin activity and the hemodynamics of patients with Hepatic Encephalopathy
Time frame: Within the five-day treatment period
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