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ID
Source
Brief title
Health condition
von Willebrand disease, platelet function disorders, coagulation factor deficiencies, fibrinolysis disorders, bleeding of unknown cause
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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
Background summary
Accurate diagnosis of a bleeding disorder is mandatory for implementation of appropriate treatment. Lately, the market for haemostatic assays has been overflooded with new commercially available tests, so-called global haemostatic tests, with unsupported claims of predicting normal and abnormal haemostasis. Also the bleeding assessment tool (BAT) might be useful as a diagnostic tool for detection of patients with a possible bleeding disorder. Benefits of these ‘experimental’ tests and the BAT could be more accurate and faster detection of bleeding disorders. The experimental tests could also improve
management of patients with bleeding disorders who use prophylactic medication. These tests need validation in clinical practice.
Study objective
Benefits of the new commercially available tests could be more accurate and faster detection of bleeding disorders and better management of patients with bleeding disorders who use prophylactic medication. These tests need validation in clinical practice. With this study we will evaluate the diagnostic accuracy of the experimental assays and the bleeding assessment tool (BAT) to detect bleeding disorders and to evaluate whether or not the experimental assays can be used to monitor the effects of coagulant factor replacement therapy. Also, this study will give us more insight in the haemostatic processes of patients with bleeding disorders.
Study design
2022 analysis of diagnostic parameters of Thrombin Generation for BUC patients
2022 analysis of diagnostic parameters of ROTEM for BUC patients
07.2021: cost effectiveness analysis of MUMC protocol vs new protocol for bleeding evaluation
2020 analysis of diagnostic parameters of flowcamber for PFA-only patients
2019 analysis of diagnostic parameters of multiplate, PFA and LTA for platelet function disorders
2019 analysis of diagnostic parameters of ISTH bleeding assessment tool for bleeding disorders
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%
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9644 |
| CCMO | NL51315.068.14 |
| OMON | NL-OMON53063 |