Point of Care Testing INR in Antiphospholipid Syndrome (POCTAS)
Explaining the Differences Between Capillary INR and Plasma INR in Patients With Antiphospholipid Syndrome
Antiphospholipid syndrome (APS) is an autoimmune and prothrombotic disorder that can affect up to 10% of young people experiencing a thrombotic event. Its treatment relies on long-term anticoagulation with vitamin K antagonists (VKAs). Direct oral anticoagulants, which are simpler to use because they do not require regular blood monitoring, are contraindicated because they are associated with an increased risk of thrombotic recurrence in some patients with APS.
Patients with APS receive VKAs and must regularly have their Index Normalized Ratio (INR) measured via a cumbersome venous blood draw. Capillary INR measurement systems are already used in certain situations, such as in patients with mechanical heart valves. The use of these systems improves the quality of life of these patients and, above all, the stability of VKA therapy, thus preventing potentially serious hemorrhagic complications or thrombotic recurrences.
In antiphospholipid syndrome (APS), these systems are discouraged due to perceived differences between capillary and venous INR (the reference method). However, among the few studies on the subject, none demonstrated significant discrepancies between patients with APS and controls, and when such discrepancies were observed, the origin of this variability could not be determined. We hypothesize that the biological profile of antiphospholipid antibodies is responsible for the INR differences.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Stéphane ZUILY, MD, PhD
- Telefoonnummer: +33 03 83 15 73 54
- E-mail: stephane.zuily@univ-lorraine.fr
Studie Locaties
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Vandœuvre-lès-Nancy, Frankrijk, 54500
- CHRU de Nancy
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Onderonderzoeker:
- Denis Wahl, MD, PhD
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Hoofdonderzoeker:
- Stéphane Zuily, MD, PhD
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Contact:
- Aurélie Emmerich
- Telefoonnummer: +33 03 83 15 36 14
- E-mail: a.emmerich@chru-nancy.Fr
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Onderonderzoeker:
- Virginie Dufrost, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
Patients with APS treated with vitamin K antagonists (VKAs)
- Patients with an LA profile without aCL or anti-β2GPI (isolated LA)
- Patients with an LA and aCL + anti-β2GPI profile (triple positivity)
- Patients with another biological profile (other than isolated LA or triple positivity)
- Control patients without aCL or anti-β2GPI treated with VKAs
- Adult patients
- Patients who have undergone a prior clinical examination appropriate for the research
- Individuals who have received complete information on the organization of the research and have not objected to their participation and the use of their data
- Patients covered by a social security scheme
Exclusion Criteria:
- Patients with antiphospholipid syndrome (APS) not treated with vitamin K antagonists (VKAs)
- Women of childbearing age without effective contraception
Persons covered by Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code:
- Pregnant, parturient, or breastfeeding women
- Unemancipated minors
- Adults under legal protection (guardianship, curatorship, or protective supervision)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Lupus Anticoagulant positive patients
Patients with isolated Lupus Anticoagulant positive test only
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Point of care testing INR using Coaguchek device
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Experimenteel: Triple positive patients
Patients with triple positivity of antiphospholipid tests
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Point of care testing INR using Coaguchek device
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Experimenteel: Other antiphospholipid profile patients
Patients with another aPL profile other than isolated LAC or triple positivity
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Point of care testing INR using Coaguchek device
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Actieve vergelijker: No antiphospholipid
Patients with no antiphospholipid antibodies
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Point of care testing INR using Coaguchek device
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Discrepancy between Coaguchek and venous INR
Tijdsspanne: At enrollment
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Percentage of patients per group with a fixed 20% discrepancy between a capillary INR measured on a Coagucheck© device and a venous INR according to subgroups and variables
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At enrollment
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Discrepancy between MicroLine and venous INR
Tijdsspanne: At enrollment
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Percentage of patients per group with a fixed 20% discrepancy between a capillary INR measured on a MicroLine INR© device and a venous INR according to subgroups and variables
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At enrollment
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Discrepancy between Coaguchek and MicroLine INR
Tijdsspanne: At enrollment
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Percentage of patients per group with a fixed 20% discrepancy between a capillary INR measured on a Coagucheck© and MicroLine devices according to subgroups and variables
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At enrollment
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
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Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2024-A01316-41
Plan Individuele Deelnemersgegevens (IPD)
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