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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Derivation cohort | In the derivation cohort, we will determined the conversion factor linking apixaban, rivaroxaban, fondaparinux, or danaparoid measured level, on the one hand, and heparin anti-Xa activity, on the other hand. |
| |
| Validation cohort | In the validation cohort, for each tested anticoagulant, we will used the conversion factor determined in the derivation cohort to infer the estimated level of anticoagulant from heparin anti-Xa activity: estimated anticoagulant level = conversion factor for this anticoagulant × heparin anti-Xa activity The agreement between measured and estimated levels of each factor-Xa inhibitor will be assessed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estimated anticoagulant level (conversion factor x anti-Xa activity) | Diagnostic Test | Estimated anticoagulant level (conversion factor x anti-Xa activity) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Agreement between measured and estimated levels of each factor-Xa inhibitor | 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. | 2 years |
| Measure | Description | 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 |
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Inclusion Criteria :
Exclusion Criteria :
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Adult patients treated with apixaban or rivaroxaban or danaparoid or fondaparinux
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elodie BOISSIER | Contact | 330240165465 | elodie.boissier@chu-nantes.fr | |
| Annick COULON | Contact | 330253482835 | bp-prom-regl@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes University Hospital | Recruiting | Nantes | Loire-Atlantique | 44093 | France |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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