NCT00006166

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 1997

Longer than P75 for phase_3

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1997

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2000

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2001

Completed
Last Updated

January 13, 2010

Status Verified

January 1, 2010

First QC Date

August 8, 2000

Last Update Submit

January 12, 2010

Conditions

AscitesLiver Cirrhosis

Keywords

refractory ascitesparacenteses

Interventions

Transjugular intrahepatic portasystemic shunts (TIPS)PROCEDURE
Total paracentecis (TP)PROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Miami Hospital

Miami, Florida, 33136-1038, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-2000, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97201, United States

Location

Medical College of Virginia Hospitals

Richmond, Virginia, 23298-0711, United States

Location

University of Washington Medical Center

Seattle, Washington, 98105, United States

Location

The Toronto Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

AscitesLiver Cirrhosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System DiseasesFibrosis

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

August 8, 2000

First Posted

August 9, 2000

Study Start

March 1, 1997

Study Completion

October 1, 2001

Last Updated

January 13, 2010

Record last verified: 2010-01

Locations

US(5)CA(1)