Von Willebrand Factor to Predict Postoperative Outcome

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT02118545

Collaborator

(none)

133

Enrollment

Locations

33.3

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Dysfunction Morbidity Mortality Hospitalisation

Study Design

Study Type:

Observational

Actual Enrollment :

133 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
vWF and postoperative Outcome An independent prospective validation cohorts will be obtained from 4 different Institutions: 2 in Vienna , 1 in Salzburg and 1 in Bern

Outcome Measures

Primary Outcome Measures

Number of Participants with Postoperative Liver Dysfunction [90 postoperative days]
Preoperative vWF-Ag Predicts Postoperative Liver Dysfunction after Liver Resection

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Paracelsus Medical University	Salzburg	Austria
2	Medical University Vienna	Vienna	Austria	1090
3	Rudolf Foundation Clinic	Vienna	Austria
4	University Hospital Bern	Bern	Switzerland