Multicentric Prospective Validation of a Universal Test to Quantify Apixaban, Rivaroxaban, Danaparoid and Fondaparinux Levels (UniXa)

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: Venous Thromboembolism; Atrial Fibrillation; Anticoagulation

Treatments: Diagnostic Test: Estimated anticoagulant level (conversion factor x anti-Xa activity)

Study type: Observational

Funder types: Other

Identifiers

NCT04539301

RC20_0061

Details and patient eligibility

About

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.

Enrollment: 2,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

2,100 participants in 2 patient groups

Derivation cohort

Description:

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.

Treatment:

Diagnostic Test: Estimated anticoagulant level (conversion factor x anti-Xa activity)

Validation cohort

Description:

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.

Treatment:

Diagnostic Test: Estimated anticoagulant level (conversion factor x anti-Xa activity)