Development of a finger stick based whole blood micro-assay for the rapid detection of Von Willebrand Disease
Completed
- Conditions
- Bleeding disordercoagulation disorder1006447710005330
- Registration Number
- NL-OMON43261
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
- Age: 18 years or older
- Previously confirmed Von Willebrand Disease, diagnosed in accordance with SSC-ISTH guidelines
- Willing and be able to understand the study information and sign the informed consent form
Exclusion Criteria
- Documented history of persisting severe anaemia (defined as haemoglobin <6.0 mmol/L for men and women)
- Use of medication which may interfere with the binding of Von Willebrand Factor to platelets (cefotaxim, levofloxacin, ciprofloxacin, valproic acid)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Performance is the primary objective of this study and is defined as the<br /><br>ability of the in vitro diagnostic micro-assay to measure von Willebrand factor<br /><br>induced platelet aggregation in accordance with the golden standard diagnostic<br /><br>method, risto-cofactor activity (VWF:RCo). A correlation coefficient between<br /><br>the micro-assay and risto-cofactor activity outcome of >=0.75 in all samples is<br /><br>considered acceptable.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary performance endpoints include specificity and sensitivity of the<br /><br>micro-assay. Results should be within the confidence intervals of the golden<br /><br>standard, risto-cofactor activity (VWF:RCo).</p><br>