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

Sponsor

Nantes University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04539301

Collaborator

(none)

2,100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anticoagulation Venous Thromboembolism Atrial Fibrillation	Diagnostic Test: Estimated anticoagulant level (conversion factor x anti-Xa activity)

Study Design

Study Type:

Observational

Anticipated Enrollment :

2100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Diagnostic Test: Estimated anticoagulant level (conversion factor x anti-Xa activity) 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.	Diagnostic Test: Estimated anticoagulant level (conversion factor x anti-Xa activity) Estimated anticoagulant level (conversion factor x anti-Xa activity)

Arm

Intervention/Treatment

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.

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

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.

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]