Predictors of Bleeding Evaluation in Adult Hematologic Patients with Bleeding Tendencies. Patients with established bleeding disorders: The BePa verification study
Recruiting
- Conditions
- von Willebrand disease, platelet function disorders, coagulation factor deficiencies, fibrinolysis disorders, bleeding of unknown cause
- Registration Number
- NL-OMON29235
- Lead Sponsor
- MUMC+
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Patients with established bleeding disorders (hemophilia A, B, other factor defects and VWD or platelet function defects) are recruited from the hemophilia treating centre ZON.
Age = 18 years
Signed informed consent
Exclusion Criteria
Pregnancy (or lactating)
Current active bleeding due to medical interventions or surgical/obstetric causes
Use of any interfering medication < 48 hours before laboratory testing
Known platelet level lower than 100,000/µl
Known hematocrite lower than 30%
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic parameters such as sensitivity, specificity, likelihood ratios and AUC with 95% confidence intervals of the experimental haemostatic tests for detection of a bleeding disorder.
- Secondary Outcome Measures
Name Time Method Changes in experimental test results before and after prophylactic medication within patients with bleeding disorders who receive prophylactic medication. These changes will be compared to changes in plasma factor levels to evaluate whether experimental tests can detect normalisation/increase of coagulant factor levels