Value of Von Willebrand Factor in Portal Hypertension

• Conditions: Liver Cirrhosis; Portal Hypertension

• Registration Number: NCT01358123
• Lead Sponsor: Medical University of Vienna

Brief Summary

In patients with liver cirrhosis elevated levels of von Willebrand factor antigen (vWF-Ag) are found frequently but the clinical significance is unclear. vWF-Ag plays an important role in primary haemostasis and development of thrombotic vascular obliteration is discussed as a possible mechanism leading to portal hypertension. Invasive measurement of hepatic venous pressure gradient (HVPG) is the current gold standard for the diagnosis of portal hypertension. The investigators hypothesize that vWF-Ag levels in plasma may correlate with portal pressure and predict clinically significant portal hypertension (CSPH, HVPG \>=10mmHg) and its complications.

Detailed Description

Patients with alcoholic, viral (chronic hepatitis C), and cryptogenic liver cirrhosis are included. Portal hemodynamics are assessed by HVPG measurement, vWF-Ag levels were measured by ELISA. Results will be compared. 3 and 6 months mortality will be recorded.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2011-05-18
• Study First Submitted QC: 2011-05-20
• Study First Posted: 2011-05-23
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-25
• Primary Completion: 2016-05
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Liver cirrhosis

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Exclusion Criteria

• no HVPG measurement

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
von Willebrand Factor Ag Level	at first visit (HVPG Measurement) (day 1)	von Willebrand Factor Antigen Levels are measured via ELISA and compared /corrlated to Hepatic Venous Pressure Gradient (HVPG). von Willebrand Factor Antigen levels are drawn and analyzed at the day of HVPG measurement. No follow up measurements will be performed, survival will be measured as secondary outcome parameter

Secondary Outcome Measures

Name	Time	Method
Overall Mortality	3 Months	Survival of Patients after index measurement of von Willebrand Factor and HVPG

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria