CHU clermont-ferrand
Clermont-Ferrand, France
NCT Number: NCT05416190
The aim is to assess the effect of injectable anticoagulants (unfractionated heparin (UFH), low molecular weight heparins (LMWH), fondaparinux, danaparoid, argatroban) on lupus anticoagulant testing assays over broad anti-Xa activity ranges and to establish their potential for causing false-positive or false-negative results.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Clermont-Ferrand, France
Citrated whole blood was collected from subjects with positive lupus anticoagulant (LA) testing and from subjects with negative LA testing. Injectable anticoagulants were prepared in demineralized water and added to plasma samples LA+ and LA- to obtain broad anti-Xa activity ranges. Anti-Xa measurement and LA testing were performed in neat and spiked plasma samples. LA testing was performed with 4 different analyzer-reagent combinations to represent almost all hemostasis manufacturers currently available. There will be no direct comparison between the LA+ and LA- groups, the objective is to evaluate the effect of increasing concentrations of injectable anticoagulants on these 2 distinct populations.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For the LA- group:
For the LA+ group:
Exclusion criteria
For all subjects:
The patient will have a visit during which a blood sample will be taken, a clinical examination will be performed, and data will be collected.
Time frame: day 1
Concerning the impact of injectable anticoagulants on the final diagnosis of LA testing (negative or positive), in a population of LA+ and LA- subjects, particular attention will be paid to the study of false negatives and false positives expressed in % and 95% confidence intervals.
Time frame: day 1
comparison of clotting times in the absence and presence of increasing concentrations of anticoagulants will be carried out by Anova or non-parametric Kruskal-Wallis test if the conditions of Anova are not respected. Graphical representations will be associated with these analyses.
Time frame: day1
comparison of clotting times in the absence and presence of increasing concentrations of anticoagulants will be carried out by Anova or non-parametric Kruskal-Wallis test if the conditions of Anova are not respected.
University Hospital, Clermont-Ferrand
Other
Acronym: ANTICOLA
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