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

Recruiting

• Conditions: Cirrhosis, Liver; Transjugular Intrahepatic Portosystemic Shunt (TIPS)

• Registration Number: NCT03973372
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

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 Timeline

• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-04
• Study Start: 2019-06-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-07
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To prospectively collect clinical information on the use and outcomes associated with contemporary real-world practice of Transjugular Intrahepatic Portosystemic Shunts (TIPS)	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.
The goals of the ALTA consortium are to answer key clinical questions related to contemporary patterns of TIPS usage as well as clinical outcomes.	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?
Create a database that will serve to inform and answer clinically related questions about the optimization of TIPS and management.	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.

Trial Locations

Locations (14)

Stanford; 🇺🇸 Redwood City, California, United States

Weill Cornell; 🇺🇸 New York, New York, United States

Baylor Scott & White Liver Consultants of Texas; 🇺🇸 Dallas, Texas, United States

Northwestern; 🇺🇸 Chicago, Illinois, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

University of Arizona; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

Scripps Health; 🇺🇸 San Diego, California, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Columbia University; 🇺🇸 New York, New York, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

University of Wisconsin Madison; 🇺🇸 Madison, Wisconsin, United States