NCT01358123

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

9.7 years

First QC Date

May 18, 2011

Last Update Submit

September 24, 2015

Conditions

Liver CirrhosisPortal Hypertension

Keywords

liver cirrhosisportal hypertensionsurvivalvon willebrand factorhepatic venous pressure gradient

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Overall Mortality

    3 Months

Eligibility Criteria

Age18 Years - 98 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Liver cirrhosis

You may not qualify if:

  • no HVPG measurement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisHypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Arnulf Ferlitsch, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnulf Ferlitsch, MD

CONTACT

+43140400arnulf.ferlitsch@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 18, 2011

First Posted

May 23, 2011

Study Start

September 1, 2006

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

September 25, 2015

Record last verified: 2015-09

Locations

AU(1)