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Austrian Registry on Transjugular Intrahepatic Portosystemic Shunts (AUTIPS)

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ClinicalTrials.gov Identifier: NCT03409263
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : August 31, 2021
Sponsor:
Information provided by (Responsible Party):
Thomas Reiberger, Medical University of Vienna

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Portal Hypertension Other: Observational study

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Österreichisches Register (Inklusive Biobank) für transjuguläre Intrahepatische Portosystemischem Shunts (TIPS): AUTIPS (AUstrian TIPS Study)
Actual Study Start Date : March 28, 2018
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Observational study
    Not applicable (observational registry study)

Outcome Measures
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Primary Outcome Measures :
  1. Transplant-free survival [ Time Frame: 0-10 years ]
    Assessment of transplant-free survival after TIPS implantation


Secondary Outcome Measures :
  1. Assessment of portalhypertensive complications [ Time Frame: 0-10 years ]
    Documenting the incidence of portalhypertensive complications

  2. Assessment of hepatic encephalopathy [ Time Frame: 0-10 years ]
    Documenting the incidence of hepatic encephalopathy


Biospecimen Retention:   Samples Without DNA
Blood samples (collected during routine blood draws): chemistry, hematology, coagulation panel Ascites: WBC, PMN, protein Urine assessment: RBC, protein, sediment

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • Age 18-99 years
  • Portal hypertension
  • Anticipated or past implantation of a transjugular intrahepatic portosystemic shunt (TIPS)
  • Informed consent

Exclusion Criteria:

  • Retraction of consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409263


Contacts
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Contact: Thomas Reiberger, MD +43140400 ext 47440 thomas.reiberger@meduniwien.ac.at
Contact: Theresa Bucsics, MD +43140400 ext 65890 theresa.bucsics@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Thomas Reiberger, M.D.    +43140400 ext 47440    thomas.reiberger@meduniwien.ac.at   
Contact: Theresa Bucsics, M.D.    +43140400 ext 65890    theresa.bucsics@meduniwien.ac.at   
Sub-Investigator: Mattias Mandorfer, M.D., Ph.D.         
Sub-Investigator: Philipp Schwabl, M.D.         
Sub-Investigator: Bernhard Scheiner, M.D.         
Principal Investigator: Thomas Reiberger, M.D.         
Sub-Investigator: Theresa Bucsics, M.D.         
Sponsors and Collaborators
Thomas Reiberger
Investigators
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Principal Investigator: Thomas Reiberger, MD Medical University of Vienna
More Information
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Additional Information:

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Responsible Party: Thomas Reiberger, Assoc.-Prof. Priv.-Doz. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03409263    
Other Study ID Numbers: AUTIPS 1943/2017
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Reiberger, Medical University of Vienna:
Cirrhosis
Advanced chronic liver disease
Ascites
Variceal hemorrhage
Transjugular intrahepatic portosystemic shunt
Additional relevant MeSH terms:
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Hypertension, Portal
Liver Diseases
Digestive System Diseases