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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Stéphane ZUILY, MD, PhD
- Numéro de téléphone: +33 03 83 15 73 54
- E-mail: stephane.zuily@univ-lorraine.fr
Lieux d'étude
-
-
-
Vandœuvre-lès-Nancy, France, 54500
- CHRU de Nancy
-
Sous-enquêteur:
- Denis Wahl, MD, PhD
-
Chercheur principal:
- Stéphane Zuily, MD, PhD
-
Contact:
- Aurélie Emmerich
- Numéro de téléphone: +33 03 83 15 36 14
- E-mail: a.emmerich@chru-nancy.Fr
-
Sous-enquêteur:
- Virginie Dufrost, MD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Lupus Anticoagulant positive patients
Patients with isolated Lupus Anticoagulant positive test only
|
Point of care testing INR using Coaguchek device
|
|
Expérimental: Triple positive patients
Patients with triple positivity of antiphospholipid tests
|
Point of care testing INR using Coaguchek device
|
|
Expérimental: Other antiphospholipid profile patients
Patients with another aPL profile other than isolated LAC or triple positivity
|
Point of care testing INR using Coaguchek device
|
|
Comparateur actif: No antiphospholipid
Patients with no antiphospholipid antibodies
|
Point of care testing INR using Coaguchek device
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Discrepancy between Coaguchek and venous INR
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Discrepancy between MicroLine and venous INR
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2024-A01316-41
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .