Vascular Liver Disease Evaluation, Follow Up and Non-Invasive Diagnostics Program

NCT03717792 | Recruiting

• 1 other identifier: VALID
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Background Vascular liver disorders (VALDI) are rare diseases, for which knowledge on risk factors, appropriate methods of diagnosis, effect of therapy and prognosis still need to be improved. Aim of the study This project aims to study risk factors, methods of detection, therapy and prognosis in order to elaborate and disseminate updated recommendations for the optimal management of patients with VALDI. Design of the study Data on patients will be collected from baseline (the date of diagnosis) up to 3 years. During this period, data on clinical condition, laboratory results, diagnostic tests, interventions and outcome will be collected anonymously using standardised review of medical charts by one special trained investigator. Only patients with VALDI are eligible to participate.

Conditions

Vascular Disorder of Liver

Outcome Measures

Primary Outcomes (1)

• Complications of Portal Hypertension

  Ascites, Varices, Bleeding, Encephalpathy, Thrombosis

  up to 3 years

Secondary Outcomes (1)

• Mortality

  up to 3 years

Interventions

no intervention OTHER

no intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We include all patients above 18 years of age with vascular liver disease diagnosed according to EASL Clinical Practice Guideline.

You may qualify if:

• all patients with vascular liver disease

You may not qualify if:

• patients without vascular liver disease

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University Hospital Bonn

Bonn, Germany

RECRUITING

Study Officials

• Michael Praktiknjo, MD

  University of Bonn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Praktiknjo, MD

CONTACT

+4922828715770; michael.praktiknjo@ukbonn.de

Johannes Chang, MD

CONTACT

+4922828715770; johannes.chang@ukbonn.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2018
• First Posted: October 24, 2018
• Study Start: January 1, 2010
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 5, 2021

Record last verified: 2021-10

Locations

DE (1)