Multicentric Prospective Validation of a Universal Test to Quantify Apixaban, Rivaroxaban, Danaparoid and Fondaparinux Levels
Overview
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.
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: January 1, 2023
Interventions
- Diagnostic Test: Estimated anticoagulant level (conversion factor x anti-Xa activity)
- Estimated anticoagulant level (conversion factor x anti-Xa activity)
Arms, Groups and Cohorts
- 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.
Clinical Trial Outcome Measures
Primary Measures
- Agreement between measured and estimated levels of each factor-Xa inhibitor
- Time Frame: 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 Measures
- Evaluation of the performance of the estimated anticoagulant level method by an inter-laboratory comparison program
- Time Frame: 2 years
- Cost comparison (estimated anticoagulant level method versus specific dosage)
- Time Frame: 2 years
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Nantes University Hospital
- Provider of Information About this Clinical Study
- Sponsor
- Overall Contact(s)
- Elodie BOISSIER, 330240165465, elodie.boissier@chu-nantes.fr
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