Actively Recruiting

Age: 18Years - 99Years
All Genders
ID03409263

Austrian Registry and Biobank for Transjugular Intrahepatic Portosystemic Shunts (TIPS): AUTIPS (AUstrian TIPS Study)

Led by Thomas Reiberger · Updated on 2024-11-06

400

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

T

Thomas Reiberger

Lead Sponsor

A

Austrian Association of Gastroenterology and Hepatology

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research focuses on patients with portal hypertension, a serious complication often arising from advanced chronic liver disease and liver cirrhosis. The study aims to document the clinical course of patients who have undergone or are expected to undergo a transjugular intrahepatic portosystemic shunt (TIPS) procedure. It also evaluates biomarkers that might predict complications following the TIPS implantation. The study is a prospective registry designed to collect long-term outcome data, addressing a gap in existing knowledge about the effects of TIPS over time. The study involves observing patients who have had or will have a TIPS procedure. Since this is an observational registry study, no experimental treatments are administered. Instead, the clinical progress of participants is carefully tracked, including medical surveillance and patient stratification, reflecting improvements in stent grafts and care practices over recent years. The study does not involve any invasive interventions beyond the standard TIPS procedure. Participants will be monitored over a period extending up to 10 years. Researchers will assess transplant-free survival as the primary outcome and will also evaluate complications related to portal hypertension and hepatic encephalopathy. Patient-reported quality of life is measured using established questionnaires such as SF36v2 and CLDQ. Throughout the study, clinical data and biomarkers will be collected and analyzed to better understand the long-term effects of TIPS and associated complications.

CONDITIONS

Brief Title

Austrian Registry on Transjugular Intrahepatic Portosystemic Shunts

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 99 years
  • Diagnosis of portal hypertension
  • Anticipated or past implantation of a transjugular intrahepatic portosystemic shunt (TIPS)
  • Ability to give informed consent
Not Eligible

You will not qualify if you...

  • Withdrawal of consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 10 years

Participants who have undergone TIPS intervention are observed to assess clinical outcomes and complications over time.

Regular follow-up visits depending on clinical course

Trial Site Locations

Total: 1 location

1

Medical University of Vienna

Vienna, State of Vienna, Austria, 1090

Actively Recruiting

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Research Team

T

Thomas Reiberger, MD

L

Lukas Hartl, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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