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

History of Changes

Tracking Information
First Received Date ^ICMJE	February 2, 2006
Last Updated Date	June 11, 2012
Start Date ^ICMJE	August 2000
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: February 2, 2006)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00287235 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 2, 2006)	The secondary objectives were to assess the time to improvement of HE by 2 grades and the effects of ECAD on laboratory parameters.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Molecular Adsorbent Recirculating System (MARS) for Patients With Cirrhosis and Hepatic Encephalopathy
Official Title ^ICMJE	A Prospective, Controlled Study Evaluating Extracorporeal Albumin Dialysis Using the Molecular Adsorbent Recirculating System (MARS) for Patients With Cirrhosis and Hepatic Encephalopathy
Brief Summary	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.
Detailed Description	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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hepatic Encephalopathy Liver Failure Hepatitis, Chronic Liver Cirrhosis
Intervention ^ICMJE	Device: Molecular Adsorent Recirculating System (MARS)
Study Arm (s)	Not Provided
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	70
Completion Date	April 2004
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients with cirrhosis and hepatic encephalopathy grades 3 and 4 At least 18 years old Signed consent of legally appointed representatives Exclusion Criteria: 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 Hemodynamically unstable or on vasopressor agents for blood pressure support more than 3 ug dopamine /min/kg body weight. On acute or chronic hemodialysis or continuous renal replacement therapy (CRRT) at the time of randomization 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Belgium, Denmark

Administrative Information
NCT Number ^ICMJE	NCT00287235
Other Study ID Numbers ^ICMJE	MARS HE Study
Has Data Monitoring Committee	Not Provided
Responsible Party	Tarek Hassanein, SCTI Research Foundation
Study Sponsor ^ICMJE	Tarek Hassanein
Collaborators ^ICMJE	Sponsor of study was Teraklin, AG and Gambro, Inc.
Investigators ^ICMJE	Not Provided
Information Provided By	SCTI Research Foundation
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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