Status:
COMPLETED
Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)
Lead Sponsor:
Vantive Health LLC
Collaborating Sponsors:
Gambro Renal Products, Inc.
Baxter Healthcare Corporation
Conditions:
Hepatic Encephalopathy
Liver Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 i...
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 ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00287235
Start Date
September 1 2000
End Date
April 1 2004
Last Update
March 3 2025
Active Locations (8)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
University of California, San Diego
San Diego, California, United States, 92103-8707
3
Northwestern University
Chicago, Illinois, United States, 60611
4
University of Michigan
Ann Arbor, Michigan, United States, 48109