Effect of Injectable Anticoagulants on Research for a Circulating Lupus-type Anticoagulant
- Conditions
- Antiphospholipid SyndromeAnticoagulant Drugs
- Interventions
- Diagnostic Test: Lupus anticoagulant testing
- Registration Number
- NCT05416190
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 188
- 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.
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group/Cohort 2: Lupus anticoagulant testing Without a previous thrombosis and considered healthy on the basis of the interview and clinical examination. Without coagulation disease. Group/Cohort 1 : Lupus anticoagulant testing Notion of the presence of lupus anticoagulant (according to ISTH criteria) and whose last test was positive
- Primary Outcome Measures
Name Time Method Results of lupus anticoagulant testing: positive or negative 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.
- Secondary Outcome Measures
Name Time Method Effect of injectable anticoagulants on the clotting times of each of the tests involved in LA testing (detection, mixing and confirmation tests). 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.
Determination of the threshold limits of injectable anticoagulants (anti-Xa activities) allowing a reliable LA diagnosis, for each analytical solution tested (analyzer/reagent combinations). 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.
Trial Locations
- Locations (1)
CHU clermont-ferrand
🇫🇷Clermont-Ferrand, France