Clinical trial NCT05416190: Effect of Injectable Anticoagulants on Research for a Circulating Lupus-type Anticoagulant
Official title: Effect of Injectable Anticoagulants on Research for a Circulating Lupus-type Anticoagulant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antiphospholipid Syndrome
Anticoagulant Drugs
Keywords: Lupus coagulation inhibitor
Anticoagulant drugs
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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-.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Results of lupus anticoagulant testing: positive or negative
timeFrame: day 1
Secondary outcomes:
measure: Effect of injectable anticoagulants on the clotting times of each of the tests involved in LA testing (detection, mixing and confirmation tests).
timeFrame: day 1
measure: Determination of the threshold limits of injectable anticoagulants (anti-Xa activities) allowing a reliable LA diagnosis, for each analytical solution tested (analyzer/reagent combinations).
timeFrame: day1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Laurie TALON
role: PRINCIPAL_INVESTIGATOR
References: