Antiphospholipid Syndrome Clinical Trial
— ANTICOLAOfficial title:
Effect of Injectable Anticoagulants on Research for a Circulating Lupus-type Anticoagulant
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.
Status | Recruiting |
Enrollment | 336 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - For all subjects: - Adult male or female subject. - In capacity to give informed consent to participate in the research. - Affiliated to a Social Security system. For the LA- group: - Without a previous thrombosis and considered healthy on the basis of the interview and clinical examination. - Without coagulation disease For the LA+ group: - Notion of the presence of lupus anticoagulant (according to ISTH criteria) and whose last test was positive. Exclusion Criteria: For all subjects: - Medical history considered by the investigator to be incompatible with the trial - Refused participation - Recent administration of oral or injectable anticoagulants - INR > 1.5 - Pregnant women, nursing mothers - Guardianship, curatorship, deprived of liberty, safeguard of justice |
Country | Name | City | State |
---|---|---|---|
France | CHU clermont-ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Results of lupus anticoagulant testing: positive or negative | 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. | day 1 | |
Secondary | Effect of injectable anticoagulants on the clotting times of each of the tests involved in LA testing (detection, mixing and confirmation tests). | 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. | day 1 | |
Secondary | Determination of the threshold limits of injectable anticoagulants (anti-Xa activities) allowing a reliable LA diagnosis, for each analytical solution tested (analyzer/reagent combinations). | 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. | day1 |
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