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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05416190
Other study ID # AOI 2021 TALON
Secondary ID 2021-A02743-38
Status Completed
Phase N/A
First received
Last updated
Start date June 2, 2022
Est. completion date May 21, 2024

Study information

Verified date June 2022
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 188
Est. completion date May 21, 2024
Est. primary completion date May 21, 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Lupus anticoagulant testing
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.

Locations

Country Name City State
France CHU clermont-ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

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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