Cirrhosis, LiverNCT03973372
ALTA TIPS: A 5-year Longitudinal Observational Study of Patients Undergoing TIPS Placement
An observational study of Cirrhosis, Liver and Transjugular Intrahepatic Portosystemic Shunt (TIPS), run by University of Texas Southwestern Medical Center at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver, Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- How many people
- 852 participants
- Where
- 14 sitesUnited States
- Study dates
- 10 Jun 2019to Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Northwestern
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Baylor Scott & White Liver Consultants of Texas
Dallas, Texas, 75246
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of Florida
Gainesville, Florida, 32608
University of Wisconsin Madison
Madison, Wisconsin, 53705
University of Minnesota
Minneapolis, Minnesota, 55455
Columbia University
New York, New York, 10032
Weill Cornell
New York, New York, 10065
University of Arizona
Phoenix, Arizona, 85006
Stanford
Redwood City, California, 94063
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Scripps Health
San Diego, California, 92121
University of California San Francisco
San Francisco, California, 94115
About this study
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
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.
Read the 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.
- Medical subject headings
- Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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?
Measured: 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.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start10 Jun 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 852 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- 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, University of Chicago, W.L.Gore & Associates, University of Minnesota, Northwestern University
- Responsible party
- Principal investigator, Lisa VanWagner, University of Texas Southwestern Medical Center
- Investigators
- Lisa VanWagner, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973372
- Sponsor's protocol ID
- STU00208288
- Status last verified
- Feb 2026
- First submitted
- 31 May 2019
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36651170Boike 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.
PubMed 34274511Boike 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.
PubMed 34158464Ge 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.
PubMed 33217178Kwong 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.
PubMed 33047893
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03973372
- Acronym / sponsor ID
- STU00208288
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 852 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- 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, University of Chicago, W.L.Gore & Associates, University of Minnesota, Northwestern University
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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?
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 36651170Bommena 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.
- Background: PubMed 34274511Boike 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.
- Background: PubMed 34158464Boike 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.
- Background: PubMed 33217178Ge 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.
- Background: PubMed 33047893Kwong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa VanWagner, MD principal investigator
University of Texas Southwestern Medical Center
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, Liver and Transjugular Intrahepatic Portosystemic Shunt (TIPS), run by University of Texas Southwestern Medical Center at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03973372, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.