Vienna Vascular Liver Disease Study

Portal Vein Thrombosis Clinical Trial

— VALID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03541057
• Other study ID #: VALID 1928/2017
• Status: Recruiting
• Start date: December 12, 2017
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Medical University of Vienna
• Contact: Thomas Reiberger, MD
• Phone: 0043140400
• Email: thomas.reiberger[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Budd-Chiari Syndrome
• Cardiac Cirrhosis
• Hypertension, Portal
• Liver Diseases
• Non-Cirrhotic Portal Hypertension
• Portal Vein Thrombosis
• Rendu Osler Weber
• Thrombosis
• Vascular Diseases
• Vascular Liver Disease

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

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