Anticoagulation, Atrial Fibrillation, Venous Thromboembolism
Conditions
Keywords
Anticoagulants (MeSH), Blood Coagulation Tests (MeSH), Drug monitoring (MeSH), Factor Xa Inhibitors (MeSH), Heparin (MeSH)
Brief summary
Despite their usefulness in perioperative and acute care settings, factor-Xa inhibitors-specific assays are scarcely available, contrary to heparin anti-Xa assay. The investigators aimed at assessing whether the widely used heparin anti-Xa assay can quantify the apixaban, rivaroxaban, fondaparinux and danaparoid levels.
Interventions
DIAGNOSTIC_TESTEstimated anticoagulant level (conversion factor x anti-Xa activity)
Estimated anticoagulant level (conversion factor x anti-Xa activity)
Sponsors
Nantes University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * Blood sample from adult patients treated with apixaban or rivaroxaban or danaparoid or fondaparinux
Exclusion criteria
: * Patients treated with unfractionated heparin or low molecular weight heparin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement between measured and estimated levels of each factor-Xa inhibitor | 2 years | An estimated anticoagulant level between 80 and 120% of the value obtained by the reference method (specific assay) will be deemed clinically acceptable, i.e. the patient's management would have been the same. |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the performance of the estimated anticoagulant level method by an inter-laboratory comparison program | 2 years |
| Cost comparison (estimated anticoagulant level method versus specific dosage) | 2 years |
Countries
France
Contacts
Primary ContactElodie BOISSIER
Backup ContactAnnick COULON
Outcome results
None listed