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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