No registrations found.
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
To assess the diagnostic parameters: sensitivity, specificity, negative predictive value, positive predictive value, likelihood ratio of the experimental haemostatic tests by comparing them to our standard diagnostic algorithm (MUMC protocol) as gold standard.
Secondary outcome
Number of patients with discrepant results in different aggregations assays (multiplate vs. LTA);
Discrepant results between PFA and vWF antigen/activity;
Optimizing cost-effectiveness in diagnostic strategies.
Background summary
Observational study of consecutive patients stratified according to a clinical bleeding score in low, intermediate and high risk bleeding tendencies; subsequently undergoing laboratory testing. Experimental haemostatic tests will be compared to the standard diagnostic work-up for bleeding evaluation according to local hospital protocol to determine their value in diagnosing bleeding disorders. Ultimately, this study will contribute in establishing a clinical prediction guideline with a high-negative and high-positive prediction value.
Study objective
Newly developed blood assays need validation before widespread implementation in clinical practice in established bleeding disorders. We will compare the results of these tests to the results of our standard protocol to determine their diagnostic value. Ultimately, this study will contribute in establishing a clinical prediction guideline with a high-negative and high-positive prediction value.
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
Age > 18 years;
Signed informed consent;
Patients with (suspected) bleeding tendency.
Exclusion criteria
Pregnancy (or lactating);
Active bleeding due to medical interventions or surgical/obstetrical causes.
The use of medication which may interfere with diagnostic tests.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL9643 |
| Other | METC AzM/MUMC : METC144036 |