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

Phase 3

Completed

• Conditions: Ascites; Liver Cirrhosis

• Registration Number: NCT00006166
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-03
• Study First Submitted: 2000-08-08
• Study First Submitted QC: 2000-08-08
• Study First Posted: 2000-08-09
• Study Completion: 2001-10
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-12
• Last Update Posted: 2010-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

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