Molecular Adsorbent Recirculating System (MARS) for Patients With Cirrhosis and Hepatic Encephalopathy

This study has been completed.
Sponsor:
Collaborator:
Sponsor of study was Teraklin, AG and Gambro, Inc.
Information provided by (Responsible Party):
Tarek Hassanein, SCTI Research Foundation
ClinicalTrials.gov Identifier:
NCT00287235
First received: February 2, 2006
Last updated: June 11, 2012
Last verified: June 2012

February 2, 2006
June 11, 2012
August 2000
Not Provided
The primary objective of the study was to compare the efficacy, safety and tolerability of ECAD using the MARS device in improving severe HE by 2 grades compared to standard medical therapy in patients with chronic ESLD during the 5 day study period.
Same as current
Complete list of historical versions of study NCT00287235 on ClinicalTrials.gov Archive Site
The secondary objectives were to assess the time to improvement of HE by 2 grades and the effects of ECAD on laboratory parameters.
Same as current
Not Provided
Not Provided
 
Molecular Adsorbent Recirculating System (MARS) for Patients With Cirrhosis and Hepatic Encephalopathy
A Prospective, Controlled Study Evaluating Extracorporeal Albumin Dialysis Using the Molecular Adsorbent Recirculating System (MARS) for Patients With Cirrhosis and Hepatic Encephalopathy

This purpose of this study is to determine the safety and efficacy of albumin dialysis using the MARS device in improving severe Hepatic Encephalopathy compared to standard medical therapy in patients with chornic ESLD.

The primary objective of the study was to compare the efficacy, safety and tolerability of ECAD using the MARS device in improving severe HE by 2 grades compared to standard medical therapy in patients with chronic ESLD during the 5 day study period. The secondary objectives were to assess the time to improvement of HE by 2 grades and the effects of ECAD on laboratory parameters.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatic Encephalopathy
  • Liver Failure
  • Hepatitis, Chronic
  • Liver Cirrhosis
Device: Molecular Adsorent Recirculating System (MARS)
Not Provided
Hassanein T, Tofteng F, Brown R, Mc Guire B, Lynch P, Mehta R, Larsen F, Gornbein J, Stange J, Blei A. Efficacy of Albumin Dialysis (MARS) in Patients with Cirrhosis and Advanced Grades of Hepatic Encephalopathy: A Prospective, Controlled, Randomized Multicenter Trial. Hepatology 2004;40:726A.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
April 2004
Not Provided

Inclusion Criteria:

  1. Patients with cirrhosis and hepatic encephalopathy grades 3 and 4
  2. At least 18 years old
  3. Signed consent of legally appointed representatives

Exclusion Criteria:

  1. Clinically significant bleeding from gastrointestinal or other site within the last 24 hours which required 2 or more units of blood to maintain a stable hemoglobin level
  2. Hemodynamically unstable or on vasopressor agents for blood pressure support more than 3 ug dopamine /min/kg body weight.
  3. On acute or chronic hemodialysis or continuous renal replacement therapy (CRRT) at the time of randomization
  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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Denmark
 
NCT00287235
MARS HE Study
Not Provided
Tarek Hassanein, SCTI Research Foundation
Tarek Hassanein
Sponsor of study was Teraklin, AG and Gambro, Inc.
Not Provided
SCTI Research Foundation
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP