Back to resultsNorth American Study for the Treatment of Refractory Ascites (NASTRA)
Primary Purpose
Ascites, Liver Cirrhosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Transjugular intrahepatic portasystemic shunts (TIPS)
Total paracentecis (TP)
Sponsored by
About this trial
This is an interventional treatment trial for Ascites focused on measuring refractory ascites, paracenteses
Eligibility 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
Sites / Locations
- University of Miami Hospital
- University of Nebraska Medical Center
- Oregon Health Sciences University
- Medical College of Virginia Hospitals
- University of Washington Medical Center
- The Toronto Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006166
First Posted
August 8, 2000
Last Updated
January 12, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00006166
Brief Title
North American Study for the Treatment of Refractory Ascites (NASTRA)
Official Title
The North American Study for the Treatment of Refractory Ascites (NASTRA) Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
March 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascites, Liver Cirrhosis
Keywords
refractory ascites, paracenteses
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Transjugular intrahepatic portasystemic shunts (TIPS)
Intervention Type
Procedure
Intervention Name(s)
Total paracentecis (TP)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136-1038
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2000
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Medical College of Virginia Hospitals
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0711
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
The Toronto Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
North American Study for the Treatment of Refractory Ascites (NASTRA)
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