Effect of Injectable Anticoagulants on Research for a Circulating Lupus-type Anticoagulant

Antiphospholipid Syndrome Clinical Trial

— ANTICOLA  

Official title:

Effect of Injectable Anticoagulants on Research for a Circulating Lupus-type Anticoagulant

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
• 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
• 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

Related Conditions & MeSH terms

• Anticoagulant Drugs
• Antiphospholipid Syndrome

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