Early TIPS for Ascites Study

Inclusion Criteria:

1. Patient has cirrhosis of the liver with portal hypertension

2. Patient has difficult to treat ascites, defined as at least one of the following:

- Subject requires paracentesis despite treatment with high dose diuretics [at
least 80 mg of furosemide (or 2 mg bumetanide) and 200 mg aldactone (or 20 mg
amiloride)] within the last 90 days

- Subject requires repeated paracentesis (cumulative volume of at least 10 L
removed) within a 45 day period

- Subject requires paracentesis and can not tolerate diuretics due to a documented
complication of diuretic therapy

3. Patient has a MELD score ≤18 prior to randomization

4. Patient is 18 years or older and <70 years old at randomization

5. Patient has a creatinine ≤ 2.0 mg/dL

6. Patient has a total bilirubin ≤3.0 mg/dL

7. Patient has a serum sodium ≥ 130 mmol/L

8. Patient is willing and able to comply with all study protocol requirements, including
specified follow-up and testing.

9. Patient, or legal authorized representative, is willing to provide written informed
consent prior to enrollment in the study.

Exclusion Criteria:

1. Patient has more than 6 large volume paracenteses of at least 5 liters each within 90
days prior to randomization

2. Patient has a history of spontaneous hepatic encephalopathy requiring hospitalization

3. Patient has hepatic encephalopathy (grade 2 or greater) not responsive to medical
management

4. Patient has known hepatocellular carcinoma

5. Patient has complete thrombosis of main portal vein

6. Patient has known pulmonary hypertension (mean PA pressure > 30 mmHg) based on
cardiac ultrasound or catheterization

7. Patient has congestive heart failure

8. Patient has active bacterial infection

9. Patient has symptomatic hepatic hydrothorax requiring repetitive thoracenteses

10. Patient has Type 1 hepatorenal syndrome (HRS)

11. Patient has Budd-Chiari syndrome

12. Patient is contraindicated for TIPS placement

13. Patient has had previous TIPS placement