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North American Study for the Treatment of Refractory Ascites (NASTRA) | Clinical Trials | Clareo Health

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

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

NCT00006166•National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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

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

Key Dates

Start Date

March 1, 1997

Completion Date

October 1, 2001

Last Updated

January 13, 2010

Conditions

AscitesLiver Cirrhosis

Interventions

Transjugular intrahepatic portasystemic shunts (TIPS)

PROCEDURE

Total paracentecis (TP)

PROCEDURE

Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation

NCT06169592

Liver CirrhosisLiver Transplant; Complications

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RECRUITING

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

NCT07275554

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis

Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer

Stop of Proton-pump Inhibitor Treatment in Patients With Liver Cirrhosis - a Double-blind, Placebo-controlled Trial

Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients