Trial record 2 of 2 for:    "acquired von Willebrand"

Acquired Von Willebrand Syndrome in Severe Aortic Stenosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Bolliger, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00805051
First received: December 8, 2008
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

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.


Condition
Bleeding
Von Willebrand Disease
Aortic Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does an Acquired Von Willebrand Syndrome Influence Perioperative Blood Loss in Patients With Severe Aortic Stenosis Undergoing Aortic Valve Replacement?

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Amount of mediastinal drainage in the first 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Amount of given blood products in the first 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: October 2008
Study Completion Date: August 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Severe aortic stenosis
Patients undergoing aortic valve replacement because of severe aortic stenosis

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients scheduled for aortic valve replacement for severe aortic stenosis

Criteria

Inclusion Criteria:

  • Severe aortic stenosis (Orifice area < 1 cm2)

Exclusion Criteria:

  • missing consent
  • severe hepatic or renal disfunction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805051

Locations
Switzerland
Department of Anaesthesia, University of Basel Hospital
Basel, Switzerland, 4000
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Miodrag Filipovic, MD Department of Anaesthesia, University of Basel Hospital
  More Information

No publications provided

Responsible Party: Daniel Bolliger, PD Dr. Daniel Bolliger, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00805051     History of Changes
Other Study ID Numbers: 07/08
Study First Received: December 8, 2008
Last Updated: September 29, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
Aortic stenosis
aortic valve replacement
von Willebrand disease
blood loss

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Von Willebrand Diseases
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 22, 2014