Portal HypertensionAUTIPSNCT03409263
Austrian Registry on Transjugular Intrahepatic Portosystemic Shunts
An observational study of Portal Hypertension, run by Thomas Reiberger at 1 site in Austria.
Trial summary
Patients with TIPS will be recruited in this prospective registry study. The clinical course will be documented and biomarkers for prediction of complicatiosn will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- Observational study
- How many people
- 400 participants
- Where
- 1 siteAustria
- Study dates
- 28 Mar 2018to 31 Dec 2027
- How long will I take part?
- 2 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients or outpatients who are scheduled for TIPS implantation, or who have recently undergone TIPS implantation and are visiting outpatienc clinics for control visits/surveillance
Who may be able to join
- Age 18-99 years
- Portal hypertension
- Anticipated or past implantation of a transjugular intrahepatic portosystemic shunt (TIPS)
- Informed consent
Who cannot join
- Retraction of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, State of Vienna, 1090
Thomas Reiberger, M.D., +43140400 ext. 47440, thomas.reiberger@meduniwien.ac.at
Lukas Hartl, M.D., +43140400 ext. 65890, lukas.a.hartl@meduniwien.ac.at
About this study
Official title: Österreichisches Register (inklusive Biobank) Für Transjuguläre Intrahepatische Portosystemischem Shunts (TIPS): AUTIPS (AUstrian TIPS Study)
Patients with TIPS will be recruited in this prospective registry study. The clinical course will be documented and biomarkers for prediction of complicatiosn will be assessed.
Read the detailed description
Patients with advanced chronic liver disease may develop portal hypertension, which is the main cause for most complications and deaths of patients with liver cirrhosis. Implantation of a transjugular intrahepatic portosystemic shunt (TIPS) leads to instantaneous alleviation of portal hypertension, but may cause hepatic encephalopathy. Stent grafts, as well as patient stratification and medical surveillance, have drastically improved over the past decades. However, there are few data on long-term outcome after TIPS implantation.This prospective registry study will assess the clinical course of patients after undergoing TIPS intervention and biomarkers for complications after TIPS implantation.
- Conditions
- Portal Hypertension
- Being tested
- Observational study
- Keywords
- Cirrhosis, Advanced chronic liver disease, Ascites, Variceal hemorrhage, Transjugular intrahepatic portosystemic shunt
- Medical subject headings
- Hypertension, Portal, Fibrosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Not applicable (observational registry study)
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant-free survival
Assessment of transplant-free survival after TIPS implantation
Measured: 0-10 years
Secondary outcomes (4)
Assessment of portalhypertensive complications
Incidence of portalhypertensive complications
Measured: 0-10 years
Assessment of hepatic encephalopathy
Incidence of hepatic encephalopathy
Measured: 0-10 years
Assessment of Patient Reported Quality of Life (SF36v2)
Validated Questionnaire: SF36v2 pre TIPS and after TIPS. The SF36 consists of 36 items measuring 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.
The mental (MCS) and physical (PCS) component summary scores, as the main read-outs of the SF-36 form, can be regarded as physiological ('normal') when the calculated score lies between 45 and 55, because the results are normalized to a normal "reference" population assigned 50 points. Scores below 45 define worse-than-average physical (PCS) or mental (MCS) health, while scores above 55 indicate better-than-average physical (PCS) or mental (MCS) health, when compared to a normal population.
Measured: 0-10 years
Assessment of Patient Reported Quality of Life (CLDQ)
Validated Questionnaire CLDQ pre TIPS and after TIPS The CLDQ includes 29 items in the following domains: abdominal symptoms, fatigue, systemic symptoms, activity, emotional function and worry. The responses in the 29 CLDQ items, respectively, are recorded on scales ranging from in 1 ("none of the time") to 7 ("all of the time").
Measured: 0-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start28 Mar 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Thomas Reiberger
- Sponsor type
- University, hospital or other
- Collaborators
- Austrian Association of Gastroenterology and Hepatology
- Responsible party
- Sponsor-investigator, Thomas Reiberger, Medical University of Vienna
- Investigators
- Thomas Reiberger, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409263
- Sponsor's protocol ID
- AUTIPS 1943/2017
- Acronym
- AUTIPS
- Status last verified
- Nov 2024
- First submitted
- 18 Jan 2018
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data may not be shared publicly due to local data safety regulations. Please contact the sponsor for more information.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Österreichisches Register (inklusive Biobank) Für Transjuguläre Intrahepatische Portosystemischem Shunts (TIPS): AUTIPS (AUstrian TIPS Study)
- ClinicalTrials.gov ID
- NCT03409263
- Acronym / sponsor ID
- AUTIPS / AUTIPS 1943/2017
- Conditions
- Portal Hypertension
- Keywords
- Cirrhosis, Advanced chronic liver disease, Ascites, Variceal hemorrhage, Transjugular intrahepatic portosystemic shunt
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Thomas ReibergerUniversity, hospital or other
- Collaborators
- Austrian Association of Gastroenterology and Hepatology
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Jan 2018 (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.
Patients with TIPS will be recruited in this prospective registry study. The clinical course will be documented and biomarkers for prediction of complicatiosn will be assessed.
Detailed description
Patients with advanced chronic liver disease may develop portal hypertension, which is the main cause for most complications and deaths of patients with liver cirrhosis. Implantation of a transjugular intrahepatic portosystemic shunt (TIPS) leads to instantaneous alleviation of portal hypertension, but may cause hepatic encephalopathy. Stent grafts, as well as patient stratification and medical surveillance, have drastically improved over the past decades. However, there are few data on long-term outcome after TIPS implantation.This prospective registry study will assess the clinical course of patients after undergoing TIPS intervention and biomarkers for complications after TIPS implantation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients or outpatients who are scheduled for TIPS implantation, or who have recently undergone TIPS implantation and are visiting outpatienc clinics for control visits/surveillance
Key inclusion criteria (4 listed)
- Age 18-99 years
- Portal hypertension
- Anticipated or past implantation of a transjugular intrahepatic portosystemic shunt (TIPS)
- Informed consent
Key exclusion criteria (1 listed)
- Retraction of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyNot applicable (observational registry study) | Other | – |
Primary outcome
Transplant-free survival
Time frame: 0-10 years
Assessment of transplant-free survival after TIPS implantation
4 secondary outcomes
Assessment of portalhypertensive complications
Time frame: 0-10 years
Assessment of hepatic encephalopathy
Time frame: 0-10 years
Assessment of Patient Reported Quality of Life (SF36v2)
Time frame: 0-10 years
Assessment of Patient Reported Quality of Life (CLDQ)
Time frame: 0-10 years
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 6 Nov 2024.
- Individual participant dataSharing planned: No. Individual participant data may not be shared publicly due to local data safety regulations. Please contact the sponsor for more information.
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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.
Thomas Reiberger, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Hypertension, run by Thomas Reiberger at 1 site in Austria.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Contact Thomas Reiberger, MD (+43140400 ext. 47440, thomas.reiberger@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant-free survival (time frame: 0-10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2024.