Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Value of Von Willebrand Factor in Portal Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Medical University of Vienna
Information provided by (Responsible Party):
Arnulf Ferlitsch, MD, Medical University of Vienna Identifier:
First received: May 18, 2011
Last updated: January 12, 2015
Last verified: January 2015

May 18, 2011
January 12, 2015
September 2006
May 2016   (final data collection date for primary outcome measure)
von Willebrand Factor Ag Level [ Time Frame: at first visit (HVPG Measurement) (day 1) ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01358123 on Archive Site
Overall Mortality [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Survival of Patients after index measurement of von Willebrand Factor and HVPG
Same as current
Not Provided
Not Provided
Value of Von Willebrand Factor in Portal Hypertension
Von Willebrand Factor As Non-Invasive Predictor Of Clinically Significant Portal Hypertension And Mortality In Patients With Liver Cirrhosis

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.

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.

Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with liver cirrhosis of all etioloiges, routinely scheduled for routine HVPG measurement will systematically be included during the study period

  • Liver Cirrhosis
  • Portal Hypertension
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2016
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Liver cirrhosis

Exclusion Criteria:

  • no HVPG measurement
18 Years and older
Contact: Arnulf Ferlitsch, MD +43140400
Not Provided
Arnulf Ferlitsch, MD, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Arnulf Ferlitsch, MD Medical University of Vienna
Medical University of Vienna
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP