Acquired Von Willebrand Syndrome in Severe Aortic Stenosis | NCT00805051

Studies
Acquired Von Willebrand Syndrome in Severe Aortic Stenosis

NCT00805051

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Sep 30, 2011Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Bleeding
Von Willebrand Disease
Aortic Stenosis

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

May 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Dec 8, 2008

First Submission Date that Met QC Criteria

Dec 8, 2008

First Posted Date

Dec 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2011

Last Update Posted Date

Sep 30, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Daniel Bolliger, PD Dr. Daniel Bolliger, University Hospital, Basel, SwitzerlandPrincipal Investigator

Lead Sponsor

University Hospital, Basel, SwitzerlandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Severe aortic stenosis		Patients undergoing aortic valve replacement because of severe aortic stenosis

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Severe aortic stenosis (Orifice area < 1 cm2)

Exclusion Criteria:

missing consent
severe hepatic or renal disfunction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled for aortic valve replacement for severe aortic stenosis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Miodrag Filipovic, MD	Department of Anaesthesia, University of Basel Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesia, University of Basel Hospital		Basel		4000	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage
D014842	von Willebrand Diseases
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided