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ALTA TIPS: A 5-year Longitudinal Observational Study of Patients Undergoing TIPS Placement

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ClinicalTrials.gov Identifier: NCT03973372
Recruitment Status : Enrolling by invitation
First Posted : June 4, 2019
Last Update Posted : August 13, 2019
Sponsor:
Collaborators:
University of California, San Francisco
Scripps Health
University of Wisconsin, Madison
University of Florida
University of Arizona
Stanford University
Columbia University
Weill Medical College of Cornell University
Baylor Scott and White Health
Mayo Clinic
Information provided by (Responsible Party):
Lisa VanWagner, Northwestern University

Brief Summary:
ALTA is a multicenter consortium focused on the management of portal hypertension. ALTA TIPS is a longitudinal observational study of patients who are undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement. ALTA will create a database that will provide clinical parameters and outcomes of patients undergoing TIPS as part of their standard of care in hopes of answering key clinical questions.

Condition or disease
Cirrhosis, Liver Transjugular Intrahepatic Portosystemic Shunt (TIPS)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Advancing Liver Therapeutic Approaches (ALTA). The ALTA Consortium Study Group for the Management of Portal Hypertension - A 5-year Longitudinal Observational Study of Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt (TIPS) Placement
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. To prospectively collect clinical information on the use and outcomes associated with contemporary real-world practice of Transjugular Intrahepatic Portosystemic Shunts (TIPS) [ Time Frame: up to 5 years ]
    Transjugular Intrahepatic Portosystemic Shunt (TIPS) was first developed as a salvage tool for life threatening variceal bleeding or for the management of severe ascites refractory to medical therapy. Over the past decade there have been improvements in TIPS stent technology resulting in reduction in stent occlusions as well as increased experience of TIPS use. This increase in TIPS use has been paralleled by the expansion of indications for TIPS placement. As TIPS use has increased, so have the clinical questions surrounding the ideal conditions in which to successfully manage the indication for the procedure, while minimizing the unintended consequences of TIPS.

  2. The goals of the ALTA consortium are to answer key clinical questions related to contemporary patterns of TIPS usage as well as clinical outcomes. [ Time Frame: up to 5 years ]
    Recent data supports the use of TIPS for the early treatment of variceal bleeding, treatment of portal vein thrombus to permit successful liver transplantation and decompression of portal hypertension before planned abdominal surgery. Questions on TIPS use still remain. For example, what is the ideal stent diameter and degree of portal gradient pressure reduction required to optimally manage ascites or varices while minimizing hepatic decompensation and hepatic encephalopathy?

  3. Create a database that will serve to inform and answer clinically related questions about the optimization of TIPS and management. [ Time Frame: up to 5 years ]
    Currently, the major short-term complications related to TIPS are exacerbation of underlying cardiopulmonary issues andhepatic decompensation. The long-term complication, however, is hepatic encephalopathy which can often have a significant burden on quality of life and may result in additional procedures for constrainment or complete occlusion of the TIPS in severe cases. Although clinical outcomes of TIPS have been published, many of these reports are limited to single center sites with small sample sizes.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We expect about 1000 people in the entire study nationally. The study population will consist of patients over the age of 18 undergoing a TIPS procedure.
Criteria

Inclusion Criteria:

  • Subjects over the age of 18 able to provide consent or have a legally authorized consent in the event the subject is unable to consent due to a transient clinical condition
  • Subject scheduled to undergo a TIPS procedure

Exclusion Criteria:

  • Minors under the age of 18 at the time of enrollment
  • Prisoners
  • Pregnant Women
  • Subjects undergoing TIPS placement as part of an investigational study outside of usual clinical care

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): NCT03973372


Locations
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United States, Illinois
Northwestern
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
University of California, San Francisco
Scripps Health
University of Wisconsin, Madison
University of Florida
University of Arizona
Stanford University
Columbia University
Weill Medical College of Cornell University
Baylor Scott and White Health
Mayo Clinic
Investigators
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Principal Investigator: Lisa VanWagner, MD Northwestern University
  Study Documents (Full-Text)

Documents provided by Lisa VanWagner, Northwestern University:
Study Protocol  [PDF] August 8, 2019


Publications:
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Responsible Party: Lisa VanWagner, Dr., Northwestern University
ClinicalTrials.gov Identifier: NCT03973372     History of Changes
Other Study ID Numbers: STU00208288
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Digestive System Diseases