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

Recruiting

• Conditions: Venous Thromboembolism; Atrial Fibrillation; Anticoagulation
• Interventions: Diagnostic Test: Estimated anticoagulant level (conversion factor x anti-Xa activity)

• Registration Number: NCT04539301
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-04
• Study Start: 2021-04-01
• Status Verified: 2024-05
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Derivation cohort	Estimated anticoagulant level (conversion factor x anti-Xa activity)	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	Estimated anticoagulant level (conversion factor x anti-Xa activity)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France