Value of Von Willebrand Factor in Portal Hypertension

Liver Cirrhosis Clinical Trial

Official title:

Von Willebrand Factor As Non-Invasive Predictor Of Clinically Significant Portal Hypertension And Mortality In Patients With Liver Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01358123
• Other study ID #: vwfcirr
• Status: Recruiting
• Phase: N/A
• First received: May 18, 2011
• Last updated: September 24, 2015
• Start date: September 2006
• Est. completion date: June 2016

Study information

• Verified date: September 2015
• Source: Medical University of Vienna
• Contact: Arnulf Ferlitsch, MD
• Phone: +43140400
• Email: arnulf.ferlitsch[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 98 Years

Eligibility

Inclusion Criteria:

• Liver cirrhosis

Exclusion Criteria:

• no HVPG measurement

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

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	von Willebrand Factor Ag Level	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	at first visit (HVPG Measurement) (day 1)	No
Secondary	Overall Mortality	Survival of Patients after index measurement of von Willebrand Factor and HVPG	3 Months	No