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

NCT05416190 | Completed

• 2 other identifiers: AOI 2021 TALON2021-A02743-38
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Antiphospholipid Syndrome; Anticoagulant Drugs

Keywords

Lupus coagulation inhibitor; Anticoagulant drugs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  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).

  day1

Study Arms (2)

Group/Cohort 1 :

OTHER

Notion of the presence of lupus anticoagulant (according to ISTH criteria) and whose last test was positive

Diagnostic Test: Lupus anticoagulant testing

Group/Cohort 2:

OTHER

Without a previous thrombosis and considered healthy on the basis of the interview and clinical examination. Without coagulation disease.

Diagnostic Test: Lupus anticoagulant testing

Interventions

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.

Group/Cohort 1 :; Group/Cohort 2:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Antiphospholipid Syndrome

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Study Officials

• Laurie TALON

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Patients are recruited according to their LA status (LA- or LA+).
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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-.

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: June 13, 2022
• Study Start: June 2, 2022
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: June 21, 2024

Record last verified: 2022-06

Locations

FR (1)