Hepatic EncephalopathyNCT00287235
Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)
A study testing MARS and Standard Medical Therapy in people with Hepatic Encephalopathy and Liver Failure, run by Vantive Health LLC at 8 sites in 3 countries.
Trial 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 improving severe HE by 2 grades compared to Standard Medical Therapy (SMT) in patients with chronic End Stage Liver… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Encephalopathy, Liver Failure, Hepatitis, Chronic
- What is being tested?
- MARS and Standard Medical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Sep 2000to Apr 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Alabama
Birmingham, Alabama, 35294
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
Columbia-Presbyterian Medical Center
New York, New York, 10032
University of California, San Diego
San Diego, California, 92103-8707
About this study
Official title: 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.
Read the 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 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
- Being tested
- MARS, Standard Medical Therapy
- Keywords
- Hepatic Encephalopathy, End Stage Liver Disease, Cirrhosis, MARS, Albumin Dialysis
- Medical subject headings
- Hepatic Encephalopathy, Liver Failure, Hepatitis, Chronic, Liver Cirrhosis, End Stage Liver Disease, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARSDevice
Also called ECAD, Extracorporeal Albumin Dialysis
Standard Medical TherapyDrug
Also called SMT
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Standard Medical Therapy + MARS | Experimental | Patients who were randomized to Group 1 received daily MARS treatments in addition to Standard Medical Therapy for 5 consecutive days. Receives: Device: MARS; Drug: Standard Medical Therapy |
| Group 2: Standard Medical Therapy Only | Active comparator | Patients who were randomized to Group 2 received standard medical treatment only. Receives: Drug: Standard Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-point reduction in HE score from the randomization grade
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.
Measured: Within the five-day treatment period
Secondary outcomes (3)
Magnitude, duration and time of improvement in Hepatic Encephalopathy
Measured: Within the five-day treatment period
Cognitive function and functional status of patients
Measured: Within the five-day treatment period
Renal function, serum bilirubin, bile acids, prothrombin activity and the hemodynamics of patients with Hepatic Encephalopathy
Measured: Within the five-day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startSep 2000
- Primary completionNov 2003
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gambro Renal Products, Inc., Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Tarek Hassanein, MD, Principal investigator, University of California San Diego Medical Center (UCSD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287235
- Sponsor's protocol ID
- MARS HE Study
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2006
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. doi: 10.1002/hep.21930.
PubMed 17975845
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00287235
- Acronym / sponsor ID
- MARS HE Study
- Keywords
- Hepatic Encephalopathy, End Stage Liver Disease, Cirrhosis, MARS, Albumin Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Gambro Renal Products, Inc., Baxter Healthcare Corporation
- Study start
- Sep 2000
- Primary completion
- Nov 2003 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 6 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Standard Medical Therapy + MARS | Experimental | Device: MARS, Drug: Standard Medical TherapyPatients who were randomized to Group 1 received daily MARS treatments in addition to Standard Medical Therapy for 5 consecutive days. |
| Group 2: Standard Medical Therapy Only | Active comparator | Drug: Standard Medical TherapyPatients who were randomized to Group 2 received standard medical treatment only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MARSAlso: ECAD, Extracorporeal Albumin Dialysis | Device | Group 1: Standard Medical Therapy + MARS |
| Standard Medical TherapyAlso: SMT | Drug | Group 1: Standard Medical Therapy + MARS, Group 2: Standard Medical Therapy Only |
Primary outcome
Two-point reduction in HE score from the randomization grade
Time frame: Within the five-day treatment period
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.
3 secondary outcomes
Magnitude, duration and time of improvement in Hepatic Encephalopathy
Time frame: Within the five-day treatment period
Cognitive function and functional status of patients
Time frame: Within the five-day treatment period
Renal function, serum bilirubin, bile acids, prothrombin activity and the hemodynamics of patients with Hepatic Encephalopathy
Time frame: Within the five-day treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Results publication: PubMed 17975845Hassanein 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. doi: 10.1002/hep.21930.
Related trials for Hepatic Encephalopathy
Not yet recruiting
Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
Hepatic Encephalopathy, Liver Cirrhosis
Not yet recruitingPhase 4
Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis
Liver Cirrhosis, Sleep Disturbance
Not yet recruiting
Equivalence of Electronic vs Paper-based PHES in Diagnosing Hepatic Encephalopathy
Liver Cirrhosis, Hepatic Encephalopathy (HE)
Recruiting
4D-Flow MRI Assessment of Portal Hypertension and TIPS Outcomes in Cirrhosis
Cirrhosis, Portal Hypertension
Active, not recruitingPhase 1/2
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
End-stage Liver Disease (ESLD), Cirrhosis, Liver
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek Hassanein, MD principal investigator
University of California San Diego Medical Center (UCSD)
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MARS and Standard Medical Therapy in people with Hepatic Encephalopathy and Liver Failure, run by Vantive Health LLC at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Belgium, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-point reduction in HE score from the randomization grade (time frame: Within the five-day treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00287235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.