Acquired Von Willebrand Syndrome in Severe Aortic Stenosis

September 29, 2011 updated by: Daniel Bolliger, University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4000
        • Department of Anaesthesia, University of Basel Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients scheduled for aortic valve replacement for severe aortic stenosis

Description

Inclusion Criteria:

  • Severe aortic stenosis (Orifice area < 1 cm2)

Exclusion Criteria:

  • missing consent
  • severe hepatic or renal disfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Severe aortic stenosis
Patients undergoing aortic valve replacement because of severe aortic stenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of mediastinal drainage in the first 24 hours
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Amount of given blood products in the first 24 hours
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Miodrag Filipovic, MD, Department of Anaesthesia, University of Basel Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

December 8, 2008

First Submitted That Met QC Criteria

December 8, 2008

First Posted (Estimate)

December 9, 2008

Study Record Updates

Last Update Posted (Estimate)

September 30, 2011

Last Update Submitted That Met QC Criteria

September 29, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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