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…
ID
Bron
Verkorte titel
Aandoening
von Willebrand disease, platelet function disorders, coagulation factor deficiencies, fibrinolysis disorders, bleeding of unknown cause
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Age > 18 years;
Signed informed consent;
Patients with (suspected) bleeding tendency.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Pregnancy (or lactating);
Active bleeding due to medical interventions or surgical/obstetrical causes.
The use of medication which may interfere with diagnostic tests.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9643 |
| Ander register | METC AzM/MUMC : METC144036 |