identifying Children with Hereditary Coagulation Disorders (iCHEC ): a protocol for a prospective cohort study
Recruiting
- Conditions
- Bleeding symptomsBleeding disordersStollingsstoornissen
- Registration Number
- NL-OMON21443
- Lead Sponsor
- Academic Medical Center, University of Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
Age 0-18 years, and
-History, signs or symptoms of bleeding, and/or
Exclusion Criteria
- Previous diagnosis of an inherited bleeding disorder
- Other, known, aquired cause of bleeding
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study outcome is the diagnostic accuracy of the iCHEC BAT, as reflected by the Area Under the Curve (AUC) of a Receiver Operating Characterics (ROC) curve using results from the laboratory assessment as the reference standard
- Secondary Outcome Measures
Name Time Method The secondary outcomes are the influence of age, sex and type of bleeding disorder on the total cumulative bleeding score and the score of individual bleeding items.