Molecular Adsorbent Recirculating System (MARS) for Patients With Cirrhosis and Hepatic Encephalopathy
This study has been completed.
Sponsor:
Tarek Hassanein
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatic Encephalopathy Liver Failure Hepatitis, Chronic Liver Cirrhosis |
Device: Molecular Adsorent Recirculating System (MARS) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Controlled Study Evaluating Extracorporeal Albumin Dialysis Using the Molecular Adsorbent Recirculating System (MARS) for Patients With Cirrhosis and Hepatic Encephalopathy |
Resource links provided by NLM:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
U.S. FDA Resources
Further study details as provided by SCTI Research Foundation:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- The secondary objectives were to assess the time to improvement of HE by 2 grades and the effects of ECAD on laboratory parameters.
| Estimated Enrollment: | 70 |
| Study Start Date: | August 2000 |
| Estimated Study Completion Date: | April 2004 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287235
Locations
| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States | |
| United States, California | |
| University of California, San Diego | |
| San Diego, California, United States, 92103-8707 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States | |
| United States, New York | |
| Columbia University | |
| New York, New York, United States | |
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States | |
| Belgium | |
| UZ Gasthuisberg | |
| Leuven, Belgium | |
| Denmark | |
| Rigshospitalet Copenhagen | |
| Copenhagen, Denmark | |
Sponsors and Collaborators
Tarek Hassanein
Sponsor of study was Teraklin, AG and Gambro, Inc.
More Information
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.
| Responsible Party: | Tarek Hassanein, Medical Director, SCTI Research Foundation |
| ClinicalTrials.gov Identifier: | NCT00287235 History of Changes |
| Other Study ID Numbers: | MARS HE Study |
| Study First Received: | February 2, 2006 |
| Last Updated: | June 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by SCTI Research Foundation:
|
Hepatic Encephalopathy End Stage Liver Disease Cirrhosis MARS Albumin Dialysis |
Additional relevant MeSH terms:
|
Hepatic Encephalopathy Hepatitis Hepatitis A Hepatitis, Chronic Liver Cirrhosis Fibrosis Brain Damage, Chronic Delirium Encephalitis Neurotoxicity Syndromes Liver Failure Hepatic Insufficiency Liver Diseases Digestive System Diseases Brain Diseases, Metabolic |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Metabolic Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Pathologic Processes Confusion Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders |
ClinicalTrials.gov processed this record on June 18, 2013