Vienna Vascular Liver Disease Study

Recruiting

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

• Registration Number: NCT03541057
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

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 Timeline

• Study Start: 2017-12-12
• Study First Submitted: 2018-05-06
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-30
• Last Update Posted: 2024-01-03
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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Exclusion Criteria

• withdrawal of written informed consent

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria