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

NCT03973372 | Active Not Recruiting DMC

• 1 other identifier: STU00208288
• Study Type: observational
• Target: 852
• Locations: 1 country
• Sites: 14

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.

Conditions

Transjugular Intrahepatic Portosystemic Shunt (TIPS); Cirrhosis, Liver

Outcome Measures

Primary Outcomes (3)

• To prospectively collect clinical information on the use and outcomes associated with contemporary real-world practice of Transjugular Intrahepatic Portosystemic Shunts (TIPS)

  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.

  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.

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• University of California, San Francisco: collaborator
• Scripps Health: collaborator
• University of Wisconsin, Madison: collaborator
• University of Florida: collaborator
• University of Arizona: collaborator
• Stanford University: collaborator
• Columbia University: collaborator
• Weill Medical College of Cornell University: collaborator
• Baylor Scott and White Health: collaborator
• Mayo Clinic: collaborator
• University of Chicago: collaborator
• W.L.Gore & Associates: collaborator
• University of Minnesota: collaborator
• Northwestern University: collaborator

Study Sites (14)

University of Arizona

Phoenix, Arizona, 85006, United States

Location

Stanford

Redwood City, California, 94063, United States

Location

Scripps Health

San Diego, California, 92121, United States

Location

University of California San Francisco

San Francisco, California, 94115, United States

Location

University of Florida

Gainesville, Florida, 32608, United States

Location

Northwestern

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Weill Cornell

New York, New York, 10065, United States

Location

Baylor Scott & White Liver Consultants of Texas

Dallas, Texas, 75246, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Wisconsin Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (5)

• Bommena S, Mahmud N, Boike JR, Thornburg BG, Kolli KP, Lai JC, German M, Morelli G, Spengler E, Said A, Desai AP, Junna S, Paul S, Frenette C, Verna EC, Goel A, Gregory D, Padilla C, VanWagner LB, Fallon MB; Advancing Liver Therapeutic Approaches (ALTA) Study Group. The impact of right atrial pressure on outcomes in patients undergoing TIPS, an ALTA group study. Hepatology. 2023 Jun 1;77(6):2041-2051. doi: 10.1097/HEP.0000000000000283. Epub 2023 Jan 19.

  PMID: 36651170 BACKGROUND

• Boike JR, Thornburg BG, Asrani SK, Fallon MB, Fortune BE, Izzy MJ, Verna EC, Abraldes JG, Allegretti AS, Bajaj JS, Biggins SW, Darcy MD, Farr MA, Farsad K, Garcia-Tsao G, Hall SA, Jadlowiec CC, Krowka MJ, Laberge J, Lee EW, Mulligan DC, Nadim MK, Northup PG, Salem R, Shatzel JJ, Shaw CJ, Simonetto DA, Susman J, Kolli KP, VanWagner LB; Advancing Liver Therapeutic Approaches (ALTA) Consortium. North American Practice-Based Recommendations for Transjugular Intrahepatic Portosystemic Shunts in Portal Hypertension. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1636-1662.e36. doi: 10.1016/j.cgh.2021.07.018. Epub 2021 Jul 15.

  PMID: 34274511 BACKGROUND

• Boike JR, Mazumder NR, Kolli KP, Ge J, German M, Jest N, Morelli G, Spengler E, Said A, Lai JC, Desai AP, Couri T, Paul S, Frenette C, Verna EC, Rahim U, Goel A, Gregory D, Thornburg B, VanWagner LB; Advancing Liver Therapeutic Approaches (ALTA) Study Group. Outcomes After TIPS for Ascites and Variceal Bleeding in a Contemporary Era-An ALTA Group Study. Am J Gastroenterol. 2021 Oct 1;116(10):2079-2088. doi: 10.14309/ajg.0000000000001357.

  PMID: 34158464 BACKGROUND

• Ge J, Lai JC, Boike JR, German M, Jest N, Morelli G, Spengler E, Said A, Lee A, Hristov A, Desai AP, Junna S, Pokhrel B, Couri T, Paul S, Frenette C, Christian-Miller N, Laurito M, Verna EC, Rahim U, Goel A, Das A, Pine S, Gregory D, VanWagner LB, Kolli KP; Advancing Liver Therapeutic Approaches (ALTA) Study Group. Nonalcoholic Fatty Liver Disease and Diabetes Mellitus Are Associated With Post-Transjugular Intrahepatic Portosystemic Shunt Renal Dysfunction: An Advancing Liver Therapeutic Approaches Group Study. Liver Transpl. 2021 Feb;27(3):329-340. doi: 10.1002/lt.25949. Epub 2021 Jan 2.

  PMID: 33217178 BACKGROUND

• Kwong AJ, Devuni D, Wang C, Boike J, Jo J, VanWagner L, Serper M, Jones L, Sharma R, Verna EC, Shor J, German MN, Hristov A, Lee A, Spengler E, Koteish AA, Sehmbey G, Seetharam A, John N, Patel Y, Kappus MR, Couri T, Paul S, Salgia RJ, Nhu Q, Frenette CT, Lai JC, Goel A; Re-Evaluating Age Limits in Transplantation (REALT) Consortium. Outcomes of Liver Transplantation Among Older Recipients With Nonalcoholic Steatohepatitis in a Large Multicenter US Cohort: the Re-Evaluating Age Limits in Transplantation Consortium. Liver Transpl. 2020 Nov;26(11):1492-1503. doi: 10.1002/lt.25863. Epub 2020 Oct 13.

  PMID: 33047893 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Baseline serum samples

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa VanWagner, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 4, 2019
• Study Start: June 10, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)