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

March 20, 2024 updated by: Lisa VanWagner, University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is a 5-year prospective, longitudinal, observational study of all patients undergoing TIPS placement. The study will accrue patients until the goal of 1,000 subjects is reached. Subjects will be followed prospectively for up to a total of 5 years. Patients will be clinically managed by their local physicians per standard of care and no specific treatments or interventions will be dictated by their enrollment in this study. Patients will be consented to enroll in the study prior to TIPS placement or within 14 days after TIPS placement (such as in the event of emergent TIPS) and their pertinent clinical information will be then collected. Subjects may be consented electronically using REDCap eConsent or docusign. Pre-TIPS participants will be asked to complete a short set of questionnaires and one verbal assessment both pre-TIPS and post-TIPS during regularly scheduled visits with their treating hepatologist. Blood and rectal samples will be collected as optional procedures, and participation in these procedures will not affect participation in the study. Patients will be asked to consent to three different 5mL blood samples (total 15mL) at the time of TIPS from the peripheral, central, and portal venous circulation. A 5 ml peripheral sample will also be collected at months 1, 6, and 12 post-TIPS. The peripheral blood samples will occur either prior to TIPS (time 0) in the IR suite or at months 1, 6 and 12 post-TIPS. The central and portal venous blood sample will occur during the TIPS procedure in the IR suite. The total blood volume collection throughout the study will be 30mL. The rectal swab will be performed by the IR/ anesthesia team prior to the TIPS procedure in the IR suite. During the prospective post-TIPS period all medical records will be reviewed including clinical notes, laboratory values, radiographic results and medication changes and this data will be inputted into the database. Participants will be asked to also complete the same questionnaires regarding their quality of life and patient reported outcomes at prespecified timepoints post-TIPS, at a minimum 3 months and 12 months post-TIPS placement and then yearly thereafter. The hepatic encephalopathy assessments and AUDIT-C questionnaire will be conducted at month 1, 3, 6,12 and then yearly thereafter as part of their usual post-TIPS care.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • University of Arizona
        • Contact:
        • Principal Investigator:
          • Michael Fallon, MD
        • Sub-Investigator:
          • Anil Seetharam, MD
    • California
      • Redwood City, California, United States, 94063
        • Recruiting
        • Stanford
        • Contact:
        • Principal Investigator:
          • Aparna Goel, MD
        • Sub-Investigator:
          • Paul Kwo, MD
      • San Diego, California, United States, 92121
      • San Francisco, California, United States, 94115
        • Recruiting
        • University of California San Francisco
        • Principal Investigator:
          • Jennifer Lai, MD
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • University of Florida
        • Contact:
        • Principal Investigator:
          • Giuseppe Morelli, MD
        • Sub-Investigator:
          • Roberto J. Firpi-Morell, MD
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60611
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • Nicholas Lim, MD
        • Sub-Investigator:
          • Shamar Young, MD
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Rochester
        • Principal Investigator:
          • Douglas Simonetto, MD
        • Contact:
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
        • Contact:
        • Principal Investigator:
          • Elizabeth Verna, MD
        • Sub-Investigator:
          • Jonathan Susman, MD
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell
        • Contact:
        • Principal Investigator:
          • Arun Jesudian, MD
        • Sub-Investigator:
          • Sonal Kumar, MD
    • Texas
      • Dallas, Texas, United States, 75390
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor Scott & White Liver Consultants of Texas
        • Contact:
        • Principal Investigator:
          • Sumeet Asrani, MD
        • Sub-Investigator:
          • Jamil Alsahhar, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Active, not recruiting
        • University of Wisconsin Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 5 years
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?
up to 5 years
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 and hepatic 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.
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Mayo Clinic
Northwestern University
University of Chicago
Columbia University
W.L.Gore & Associates
University of Wisconsin, Madison
University of Florida
Weill Medical College of Cornell University
University of California, San Francisco
Stanford University
University of Minnesota
University of Arizona
Baylor Scott and White Health
Scripps Health
Digestive Health Foundation

Investigators

  • Principal Investigator: Lisa VanWagner, MD, University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2019

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 31, 2019

First Submitted That Met QC Criteria

May 31, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00208288

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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