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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Stéphane ZUILY, MD, PhD
- Telefonnummer: +33 03 83 15 73 54
- E-post: stephane.zuily@univ-lorraine.fr
Studiesteder
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Vandœuvre-lès-Nancy, Frankrike, 54500
- CHRU de Nancy
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Underetterforsker:
- Denis Wahl, MD, PhD
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Hovedetterforsker:
- Stéphane Zuily, MD, PhD
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Ta kontakt med:
- Aurélie Emmerich
- Telefonnummer: +33 03 83 15 36 14
- E-post: a.emmerich@chru-nancy.Fr
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Underetterforsker:
- Virginie Dufrost, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Aktiv komparator: No antiphospholipid
Patients with no antiphospholipid antibodies
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Point of care testing INR using Coaguchek device
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Discrepancy between Coaguchek and venous INR
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Discrepancy between MicroLine and venous INR
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2024-A01316-41
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