Von Willebrand Factor to Predict Postoperative Outcome

Completed

• Conditions: Mortality; Liver Dysfunction; Morbidity; Hospitalisation

• Registration Number: NCT02118545
• Lead Sponsor: Medical University of Vienna

Brief Summary

vWF is stored in weibel-palade-bodies of endothelial cells as well as alpha-granula of platelets and is released upon their activation. Endothelial cell dysfunction as well as platelet activation often occur in liver disease and portal hypertension, which may lead to an increase in circulating vWF levels. Indeed, multiple studies have reported that liver disease is associated with increased circulating vWF- antigen (vWF-Ag). Furthermore, increased circulating vWF -Ag Levels have been shown to be associated with increased mortality rates in patients with chronic liver disease. Within a prospective evaluation cohort, the investigators were able to document that patients with increased vWF-Ag levels prior to liver resection suffered from an increased incidence of postoperative liver dysfunction and morbidity. Within this prospective multicenter validation study, the investigators now aim to prospectively validate that circulating vWF-Ag prior to liver resection is a valuable marker to predict postoperative clinical outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-21
• Status Verified: 2015-09
• Primary Completion: 2016-02
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

• patients undergoing liver resection
• only patients with either hepatocellular carcinoma, cholangiocellular carcinoma or colorectal cancer liver metastasis will be included

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Exclusion Criteria

• inherited coagulopathy
• age > 85

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with Postoperative Liver Dysfunction	90 postoperative days	Preoperative vWF-Ag Predicts Postoperative Liver Dysfunction after Liver Resection

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Postoperative Morbidity	90 postoperative days	Preoperative vWF-Ag Predicts Postoperative Morbidity after Liver Resection
Number of Participants with Postoperative Mortality	90 postoperative days	Preoperative vWF-Ag Predicts Postoperative Mortality after Liver Resection
Days of Postoperative Hospitalisation	90 postoperative days	Preoperative vWF-Ag Predicts Postoperative Hospitalisation after Liver Resection

Trial Locations

Locations (4)

Rudolf Foundation Clinic; 🇦🇹 Vienna, Austria

Paracelsus Medical University; 🇦🇹 Salzburg, Austria

University Hospital Bern; 🇨🇭 Bern, Switzerland

Medical University Vienna; 🇦🇹 Vienna, Austria