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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006166
First Posted: August 9, 2000
Last Update Posted: January 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Purpose
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.

Condition Intervention Phase
Ascites Liver Cirrhosis Procedure: Transjugular intrahepatic portasystemic shunts (TIPS) Procedure: Total paracentecis (TP) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The North American Study for the Treatment of Refractory Ascites (NASTRA) Clinical Trial

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Study Start Date: March 1997
Estimated Study Completion Date: October 2001
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006166


Locations
United States, Florida
University of Miami Hospital
Miami, Florida, United States, 33136-1038
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-2000
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97201
United States, Virginia
Medical College of Virginia Hospitals
Richmond, Virginia, United States, 23298-0711
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98105
Canada, Ontario
The Toronto Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

ClinicalTrials.gov Identifier: NCT00006166     History of Changes
Other Study ID Numbers: NASTRA (completed)
1R01DK051523 ( U.S. NIH Grant/Contract )
First Submitted: August 8, 2000
First Posted: August 9, 2000
Last Update Posted: January 13, 2010
Last Verified: January 2010

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
refractory ascites
paracenteses

Additional relevant MeSH terms:
Liver Cirrhosis
Ascites
Liver Diseases
Digestive System Diseases
Pathologic Processes