Performance is the primary objective of this study and is defined as the ability of the in vitro diagnostic micro-assay to measure von Willebrand factor induced platelet aggregation in accordance with the golden standard diagnostic method, risto-…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Blood and lymphatic system disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Performance is the primary objective of this study and is defined as the
ability of the in vitro diagnostic micro-assay to measure von Willebrand factor
induced platelet aggregation in accordance with the golden standard diagnostic
method, risto-cofactor activity (VWF:RCo). A correlation coefficient between
the micro-assay and risto-cofactor activity outcome of >=0.75 in all samples is
considered acceptable.
Secondary outcome
Secondary performance endpoints include specificity and sensitivity of the
micro-assay. Results should be within the confidence intervals of the golden
standard, risto-cofactor activity (VWF:RCo).
Background summary
The current diagnostic work up of Von Willebrand Disease is a labour intensive
process that involves a broad panel of sequential laboratory tests. The gold
standard test, ristocetin cofactor activity (VWF:RCo), has widely acknowledged
disadvantages with regards to variability, precision and reproducibility.
Previously, we have developed a single step micro-assay that can accurately
identify Von Willebrand Disease patients with blood obtained through
venepuncture. This assay has been optimized to need as low as 40 µl of finger
stick blood of healthy subjects. In the current study, we will use the
micro-assay on finger stick blood from Von Willebrand Disease patients. When
proven valuable, the micro-assay could be an attractive new diagnostic tool in
Von Willebrand Disease screening, especially in children.
Study objective
Performance is the primary objective of this study and is defined as the
ability of the in vitro diagnostic micro-assay to measure von Willebrand factor
induced platelet aggregation in accordance with the golden standard diagnostic
method, risto-cofactor activity (VWF:RCo).
Also, specificity and sensitivity of the micro-assay assay will be determined.
Study design
Cross sectional, monocenter, observational study
Study burden and risks
For this study, patients will endure 1 finger stick procedure, which induces a
very low risk and burden to the adult humans. The main risk associated with
this procedure is little local bruising and slight local discomfort. Patients
will be asked to participate during a regular outpatient clinic visit. No
alterations to medication or life style are introduced.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57059.041.16 |