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Completed

NCT Number: NCT05416190

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU clermont-ferrand

Clermont-Ferrand, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lupus anticoagulant testing

Diagnostic Test

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.

Primary outcomes

  1. Results of lupus anticoagulant testing: positive or negative

    Time frame: 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 outcomes

  1. Effect of injectable anticoagulants on the clotting times of each of the tests involved in LA testing (detection, mixing and confirmation tests).

    Time frame: 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.

  2. Determination of the threshold limits of injectable anticoagulants (anti-Xa activities) allowing a reliable LA diagnosis, for each analytical solution tested (analyzer/reagent combinations).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: ANTICOLA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 13, 2022
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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