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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Stéphane ZUILY, MD, PhD
- Telefonnummer: +33 03 83 15 73 54
- E-post: stephane.zuily@univ-lorraine.fr
Studieorter
-
-
-
Vandœuvre-lès-Nancy, Frankrike, 54500
- CHRU de Nancy
-
Underutredare:
- Denis Wahl, MD, PhD
-
Huvudutredare:
- Stéphane Zuily, MD, PhD
-
Kontakt:
- Aurélie Emmerich
- Telefonnummer: +33 03 83 15 36 14
- E-post: a.emmerich@chru-nancy.Fr
-
Underutredare:
- Virginie Dufrost, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Lupus Anticoagulant positive patients
Patients with isolated Lupus Anticoagulant positive test only
|
Point of care testing INR using Coaguchek device
|
|
Experimentell: Triple positive patients
Patients with triple positivity of antiphospholipid tests
|
Point of care testing INR using Coaguchek device
|
|
Experimentell: Other antiphospholipid profile patients
Patients with another aPL profile other than isolated LAC or triple positivity
|
Point of care testing INR using Coaguchek device
|
|
Aktiv komparator: No antiphospholipid
Patients with no antiphospholipid antibodies
|
Point of care testing INR using Coaguchek device
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Discrepancy between Coaguchek and venous INR
Tidsram: At enrollment
|
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
|
At enrollment
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Discrepancy between MicroLine and venous INR
Tidsram: At enrollment
|
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
|
At enrollment
|
|
Discrepancy between Coaguchek and MicroLine INR
Tidsram: At enrollment
|
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
|
At enrollment
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2024-A01316-41
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .