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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2024-05-01

Brief Summary

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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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Detailed Description

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Conditions

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Anticoagulation Venous Thromboembolism Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type DIAGNOSTIC_TEST

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

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.