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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Recruiting

CT.gov ID

NCT05416190

Collaborator

(none)

336

Enrollment

Location

Arms

Anticipated Duration (Months)

11.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Antiphospholipid Syndrome Anticoagulant Drugs	Diagnostic Test: Lupus anticoagulant testing	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

336 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Citrated whole blood was collected from all participants and lupus anticoagulant testing was performed before and after spiking in vitro injectable anticoagulants. No distinction between the groups LA+ and LA-.Citrated whole blood was collected from all participants and lupus anticoagulant testing was performed before and after spiking in vitro injectable anticoagulants. No distinction between the groups LA+ and LA-.

Masking:

None (Open Label)

Masking Description:

Patients are recruited according to their LA status (LA- or LA+).

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jun 2, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU clermont-ferrand	Clermont-Ferrand		France

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator: Laurie TALON, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier:

NCT05416190

Other Study ID Numbers:

AOI 2021 TALON
2021-A02743-38

First Posted:

Jun 13, 2022

Last Update Posted:

Jun 14, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Clermont-Ferrand

Lupus coagulation inhibitor

Anticoagulant drugs

Additional relevant MeSH terms:

Antiphospholipid Syndrome

Anticoagulants

Lupus Coagulation Inhibitor

Study Results

No Results Posted as of Jun 14, 2022