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

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

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