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

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.

Study Overview

• Status: Completed
• Conditions: Antiphospholipid Syndrome; Anticoagulant Drugs
• Intervention / Treatment: Diagnostic test: Lupus anticoagulant testing

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.

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • Chu Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group/Cohort 1 : Notion of the presence of lupus anticoagulant (according to ISTH criteria) and whose last test was positive	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.
Other: Group/Cohort 2: Without a previous thrombosis and considered healthy on the basis of the interview and clinical examination. Without coagulation disease.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Laurie TALON, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Actual): May 21, 2024
• Study Completion (Actual): May 21, 2024

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Anticoagulant drugs; Lupus coagulation inhibitor
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Antiphospholipid Syndrome; Physiological Effects of Drugs; Immunologic Factors; Anticoagulants; Lupus Coagulation Inhibitor
• Other Study ID Numbers: AOI 2021 TALON; 2021-A02743-38 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No