Acquired Von Willebrand Syndrome in Severe Aortic Stenosis

Bleeding Clinical Trial

Official title:

Does an Acquired Von Willebrand Syndrome Influence Perioperative Blood Loss in Patients With Severe Aortic Stenosis Undergoing Aortic Valve Replacement?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805051
• Other study ID #: 07/08
• Status: Completed
• Phase: N/A
• First received: December 8, 2008
• Last updated: September 29, 2011
• Start date: October 2008
• Est. completion date: August 2010

Study information

• Verified date: September 2011
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial Summary

Patients with severe aortic stenosis often suffer from an acquired Von Willebrand syndrome by degeneration of the polymers during passage through the narrow valve leading to turbulences. We hypothesized that the diagnosis of acquired von Willebrand syndrome influence perioperative blood loss in patients undergoing open cardiac valve replacement.

Description:

Patients with severe aortic stenosis often suffer from an acquired Von Willebrand syndrome by degeneration of the polymers during passage through the narrow valve leading to turbulences. After written consent and an extended anamnesis of existing coagulopathy, we take three blood samples in these patients: before surgery, on the day after surgery and 4 weeks after surgery. We determine von Willebrand factor in lab and by a point-of-care platelet function analyzer (Multiplate TM). We measure amount of mediastinal drainage after 24 hours and blood product consumption in these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Severe aortic stenosis (Orifice area < 1 cm2)

Exclusion Criteria:

• missing consent

• severe hepatic or renal disfunction

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Bleeding
• Constriction, Pathologic
• Von Willebrand Disease
• Von Willebrand Diseases

Locations

Country	Name	City	State
Switzerland	Department of Anaesthesia, University of Basel Hospital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of mediastinal drainage in the first 24 hours		24 hours	Yes
Secondary	Amount of given blood products in the first 24 hours		24 hours	Yes