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Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gambro Renal Products, Inc.
ClinicalTrials.gov Identifier:
NCT00287235
First received: February 2, 2006
Last updated: June 19, 2014
Last verified: June 2014

February 2, 2006
June 19, 2014
September 2000
November 2003   (final data collection date for primary outcome measure)
Two-point reduction in HE score from the randomization grade [ Time Frame: Within the five-day treatment period ] [ Designated as safety issue: No ]
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.
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.
Complete list of historical versions of study NCT00287235 on ClinicalTrials.gov Archive Site
  • Magnitude, duration and time of improvement in Hepatic Encephalopathy [ Time Frame: Within the five-day treatment period ] [ Designated as safety issue: No ]
  • Cognitive function and functional status of patients [ Time Frame: Within the five-day treatment period ] [ Designated as safety issue: No ]
  • Renal function, serum bilirubin, bile acids, prothrombin activity and the hemodynamics of patients with Hepatic Encephalopathy [ Time Frame: Within the five-day treatment period ] [ Designated as safety issue: Yes ]
The secondary objectives were to assess the time to improvement of HE by 2 grades and the effects of ECAD on laboratory parameters.
Not Provided
Not Provided
 
Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)
A Prospective, Controlled Study Of The Clinical Efficacy Of Albumin Dialysis Using The Molecular Adsorbent Recirculating System (MARS®) For The Treatment Of Patients With Hepatic Encephalopathy

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

Interventional
Not Provided
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: MARS
    Other Names:
    • MARS
    • ECAD
    • Extracorporeal Albumin Dialysis
  • Drug: Standard Medical Therapy
    Other Name: SMT
  • Experimental: Group 1: Standard Medical Therapy + MARS
    Patients who were randomized to Group 1 received daily MARS treatments in addition to Standard Medical Therapy for 5 consecutive days.
    Interventions:
    • Device: MARS
    • Drug: Standard Medical Therapy
  • Active Comparator: Group 2: Standard Medical Therapy Only
    Patients who were randomized to Group 2 received standard medical treatment only.
    Intervention: Drug: Standard Medical Therapy
Hassanein TI, Tofteng F, Brown RS Jr, McGuire B, Lynch P, Mehta R, Larsen FS, Gornbein J, Stange J, Blei AT. Randomized controlled study of extracorporeal albumin dialysis for hepatic encephalopathy in advanced cirrhosis. Hepatology. 2007 Dec;46(6):1853-62.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
April 2004
November 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Signed written informed consent by patient or patient's legally appointed representative
  2. Be at least 18 years of age; male or female
  3. Have chronic end stage liver disease with worsening Hepatic Encephalopathy (Grades 3,4).

Exclusion Criteria:

  1. 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
  2. Hemodynamically unstable or on vasopressor agents for blood pressure support (except for renal-dosed dopamine)
  3. On acute or chronic hemodialysis or continuous renal replacement therapy (CRRT)
  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
Yes
Gambro Renal Products, Inc.
Gambro Renal Products, Inc.
Not Provided
Principal Investigator: Tarek Hassanein, MD University of California San Diego Medical Center (UCSD)
Gambro Renal Products, Inc.
June 2014

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