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Home > "N" Clinical Trials Conditions > North American Study for the Treatment of Refractory Ascites (NASTRA)  North American Study for the Treatment of Refractory Ascites (NASTRA)
North American Study for the Treatment of Refractory Ascites (NASTRA)
For Condition: Liver Cirrhosis,Ascites
Status: Completed
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
University of Miami Hospital
Miami, Florida, 33136-1038
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-2000
United States
Oregon Health Sciences University
Portland, Oregon, 97201
United States
The Toronto Hospital
Toronto, Ontario, M5G 2C4
Canada
University of Washington Medical Center
Seattle, Washington, 98105
United States
Medical College of Virginia Hospitals
Richmond, Virginia, 23298-0711
United States
Additional Information:
Study ID Numbers: NASTRA; 1R01DK51523
Study Start Date: March 1997
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006166
Other Liver Cirrhosis Studies:
1. North American Study for the Treatment of Refractory Ascites (NASTRA)
Related Studies:
Other Liver Cirrhosis Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
North American Study for the Treatment of Refractory Ascites (NASTRA)
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