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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03541057
Other study ID # VALID 1928/2017
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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)
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