Vienna Vascular Liver Disease Study (VALID)

Vienna Vascular Liver Disease Study: Characterization of Patients With Vascular Liver Disease - a Registry With Biobank

The aim of this Register Trial is to systematically study the epidemiology, risk factors, liver function as well prognosis of patients with vascular liver diseases. Furthermore, important clinical parameters will be assessed in order to evaluate patients' coagulation status and in order to develop new biomarkers derived from blood, urine, stool or ascites of patients as well as histological samples from the upper / lower GI-tract or the liver in order to better understand the natural history of vascular liver diseases.

Study Overview

• Status: Recruiting
• Conditions: Portal Vein Thrombosis; Budd-Chiari Syndrome; Non-Cirrhotic Portal Hypertension; Vascular Liver Disease; Rendu Osler Weber; Cardiac Cirrhosis; Porto-sinusoidal Vascular Disorder

Detailed Description

We will include patients with vascular liver diseases, including

• portal vein thrombosis (PVT)
• Budd-Chiari Syndrome (BCS)
• Heredetary Hemorrhagic Teleangiectasia (HHT, or Osler-Rendu Disease)
• Noncirrhotic-portal hypertension (NCPH) and Porto-sinusoidal vascular disorder
• Cirrhosis cardiaque if the fulfill inclusion/exclusion criteria and provide written informed consent. Participation in the biobank is optional for the patients. In particular, we will study the natural course of the patients in regard to hepatic decompensation (ascites, variceal bleeding, hepatic encephalopathy), need for intensified treatment (TIPS, ICU, liver transplantation) and survival.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Thomas Reiberger, MD; Phone Number: 47410 0043140400; Email: thomas.reiberger@meduniwien.ac.at
• Study Contact Backup: Name: Bernhard Scheiner, MD; Phone Number: 47410 0043140400; Email: bernhard.scheiner@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Thomas Reiberger, MD; Phone Number: 47410 0043140400; Email: thomas.reiberger@meduniwien.ac.at
    • Contact: Bernhard Scheiner, MD; Phone Number: 47410 0043140400; Email: bernhard.scheiner@meduniwien.ac.at
    • Principal Investigator: Thomas Reiberger, MD
    • Sub-Investigator: Bernhard Scheiner, MD
    • Sub-Investigator: Mattias Mandorfer, MD
    • Sub-Investigator: Philipp Schwabl, MD
    • Sub-Investigator: Theresa Bucsics, MD
    • Sub-Investigator: Katharina Lampichler, MD
    • Sub-Investigator: Matthias Pinter, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients with a vascular liver disease (as specified above) presenting at the outpatient department / inpatient ward of the Medical University of Vienna.

Description

Inclusion Criteria:

• Diagnosis of a vascular liver disease by imaging (sonography, CT, MRI), transient elastography or liver histology
• PVT: Portal vein thrombosis
• NCPH: non-cirrhotic Portal Hypertension
• PSVD: porto-sinusoidal vascular disorder
• BCS: Budd-Chiari-Syndrome
• SOS: sinusoidal occlusive disease
• HHT: hereditary hemorrhagic teleangiectasia
• CIRCAD: cirrhosis cardiaque
• Age >18 years and <100 years
• Written informed consent obtained

Exclusion Criteria:

- withdrawal of written informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatic Decompensation	Any first hepatic decompensation: variceal bleeding, new onset of ascites, new onset of hepatic encephalopathy, new onset of jaundice	Up to 10 years (=Study Period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver-related death	Death from a liver-related cause	Up to 10 years (=Study Period)
Coagulation status	Coagulation status of the Patient as assessed by advanced coagulation tests (including TEG-ROTEM and TGA)	Up to 10 years (=Study Period)

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2017
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 6, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 30, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Venous Thrombosis; Liver Diseases; Vascular Diseases; Thrombosis; Hypertension, Portal; Budd-Chiari Syndrome
• Other Study ID Numbers: VALID 1928/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No