North American Study for the Treatment of Refractory Ascites (NASTRA)

Completed · Phase 3

Conditions studied: Ascites, Liver Cirrhosis

In brief

The NASTRA Clinical Trial is a multi-center, randomized, controlled clinical trial designed to determine if treatment with transjugular intrahepatic portasystemic shunts (TIPS) is superior to high volume paracentesis (total paracentesis, TP) for the treatment of refractory ascites due to cirrhosis. Only patients with clinically tense symptomatic ascites (shortness of breath, umbilical hernia, abdominal pain and/or distension, and/or limitation of activity) who have either diuretic-resistant ascites or diuretic-intractable ascites are being studied.

Key facts

Study ID

NCT00006166

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Starts

1997-03-01

Expected to finish

2001-10-01

Last updated by the study team

2010-01-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cirrhosis as documented by biopsy or clinical/laboratory parameters WITH
• Tense symptomatic ascites and need for paracentesis (10 L) within last 2 months AND
• Failure of medical therapy as defined by the inability to lose at least 3.3 lbs/week while on maximum doses of diuretics or diuretic related complications (severe hyponatremia, hypercalcemia, azotemia or encephalopathy)

You may not qualify if…

• Causes of ascites other than cirrhosis and portal hypertension
• Terminal liver failure
• Portal vein thrombosis
• Congestive heart failure
• Acute renal failure
• Active encephalopathy
• Alcoholic hepatitis
• Pregnancy

Where it is running

• University of Miami Hospital — Miami, Florida, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Medical College of Virginia Hospitals — Richmond, Virginia, United States
• University of Washington Medical Center — Seattle, Washington, United States
• The Toronto Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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