Clinical trial NCT03973372: ALTA TIPS: A 5-year Longitudinal Observational Study of Patients Undergoing TIPS Placement
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cirrhosis, Liver
Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Scripps Health
name: University of Wisconsin, Madison
name: University of Florida
name: University of Arizona
name: Stanford University
name: Columbia University
name: Weill Medical College of Cornell University
name: Baylor Scott and White Health
name: Mayo Clinic
name: University of Chicago
name: Digestive Health Foundation
name: W.L.Gore & Associates
name: University of Minnesota
name: Northwestern University
First posted: 2019-06-04
Enrollment: 852
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: To prospectively collect clinical information on the use and outcomes associated with contemporary real-world practice of Transjugular Intrahepatic Portosystemic Shunts (TIPS)
timeFrame: up to 5 years
measure: The goals of the ALTA consortium are to answer key clinical questions related to contemporary patterns of TIPS usage as well as clinical outcomes.
timeFrame: up to 5 years
measure: Create a database that will serve to inform and answer clinically related questions about the optimization of TIPS and management.
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: University of Arizona
state: Arizona
city: Redwood City
country: United States
facility: Stanford
state: California
city: San Diego
country: United States
facility: Scripps Health
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Weill Cornell
state: New York
city: Dallas
country: United States
facility: Baylor Scott & White Liver Consultants of Texas
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Lisa VanWagner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.