AscitesPhase 3NCT00006166
North American Study for the Treatment of Refractory Ascites (NASTRA)
A Phase 3 study testing Transjugular intrahepatic portasystemic shunts (TIPS) and Total paracentecis (TP) in people with Ascites and Liver Cirrhosis, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ascites, Liver Cirrhosis
- What is being tested?
- Transjugular intrahepatic portasystemic shunts (TIPS) and Total paracentecis (TP)
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 6 sitesin 2 countries
- Study dates
- Mar 1997to Oct 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
University of Miami Hospital
Miami, Florida, 33136-1038
University of Nebraska Medical Center
Omaha, Nebraska, 68198-2000
Oregon Health Sciences University
Portland, Oregon, 97201
Medical College of Virginia Hospitals
Richmond, Virginia, 23298-0711
University of Washington Medical Center
Seattle, Washington, 98105
About this study
Official title: The North American Study for the Treatment of Refractory Ascites (NASTRA) Clinical Trial
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.
- Conditions
- Ascites, Liver Cirrhosis
- Being tested
- Transjugular intrahepatic portasystemic shunts (TIPS), Total paracentecis (TP)
- Keywords
- refractory ascites, paracenteses
- Medical subject headings
- Ascites, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transjugular intrahepatic portasystemic shunts (TIPS)Procedure or surgery
Total paracentecis (TP)Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2000 (estimated)
- Study startMar 1997
- Study completionOct 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AscitesStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006166
- Sponsor's protocol ID
- NASTRA (completed)
- Other IDs
- 1R01DK051523
- Status last verified
- Jan 2010
- First submitted
- 8 Aug 2000
- Last updated
- 13 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The North American Study for the Treatment of Refractory Ascites (NASTRA) Clinical Trial
- ClinicalTrials.gov ID
- NCT00006166
- Acronym / sponsor ID
- NASTRA (completed)
- Conditions
- Ascites, Liver Cirrhosis
- Keywords
- refractory ascites, paracenteses
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Mar 1997
- Study completion
- Oct 2001
- First posted
- 9 Aug 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- Causes of ascites other than cirrhosis and portal hypertension
- Terminal liver failure
- Portal vein thrombosis
- Congestive heart failure
- Acute renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transjugular intrahepatic portasystemic shunts (TIPS) | Procedure or surgery | – |
| Total paracentecis (TP) | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transjugular intrahepatic portasystemic shunts (TIPS) and Total paracentecis (TP) in people with Ascites and Liver Cirrhosis, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2010.