Von Willebrand Factor to Predict Postoperative Outcome

Mortality Clinical Trial

Official title:

Preoperative Von Willebrand Factor to Predict Postoperative Liver Dysfunction and Morbidity After Liver Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118545
• Other study ID #: Vie-Sal-Ber
• Status: Completed
• Phase: N/A
• First received: April 15, 2014
• Last updated: March 7, 2016
• Start date: April 2014

Study information

• Verified date: September 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Medical University of Vienna
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• patients undergoing liver resection

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

Exclusion Criteria:

• inherited coagulopathy

• age > 85

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hospitalisation
• Liver Diseases
• Liver Dysfunction
• Morbidity
• Mortality

Locations

Country	Name	City	State
Austria	Paracelsus Medical University	Salzburg
Austria	Medical University Vienna	Vienna
Austria	Rudolf Foundation Clinic	Vienna
Switzerland	University Hospital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Countries where clinical trial is conducted

Austria,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Postoperative Liver Dysfunction	Preoperative vWF-Ag Predicts Postoperative Liver Dysfunction after Liver Resection	90 postoperative days	No
Secondary	Number of Participants with Postoperative Morbidity	Preoperative vWF-Ag Predicts Postoperative Morbidity after Liver Resection	90 postoperative days	No
Secondary	Number of Participants with Postoperative Mortality	Preoperative vWF-Ag Predicts Postoperative Mortality after Liver Resection	90 postoperative days	No
Secondary	Days of Postoperative Hospitalisation	Preoperative vWF-Ag Predicts Postoperative Hospitalisation after Liver Resection	90 postoperative days	No