Development of a finger stick based whole blood micro-assay for the rapid detection of Von Willebrand Disease

Development of a finger stick based whole blood micro-assay for the rapid detection of Von Willebrand Disease - FaST-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43261

Enrollment

Registered

2016-07-26

Start date

2016-11-14

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding disorder coagulation disorder

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Documented history of persisting severe anaemia (defined as haemoglobin

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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).	—

Countries

Netherlands

Outcome results