Blood Donation From Warfarin Users for the Development of POC INR Monitor
Blood Donation for the Development and Optimisation of the Second Generation Microvisk International Normalized Ratio (INR) Testing System for the Measurement of Prothrombin Time (PT)/INR in Patients on Warfarin Therapy.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
The number of patients receiving anticoagulation therapy with warfarin and other vitamin K antagonists has been rising in recent years. Increasing life expectancy is increasing the proportion of the population having conditions such as Atrial Fibrillation and venous thrombosis, where primary and secondary prevention of thromboembolic complications are best achieved with anticoagulation.
Unpredictable pharmacokinetics, widespread interactions with drugs and food and the narrow therapeutic window make closely monitoring Vitamin K antagonists a necessity. Portable point of care (POC) coagulometers which measure PT from capillary whole blood and provide an INR reading within a few minutes are already widely available throughout North American and Europe. They give comparable results when compared to laboratory based systems are popular with patients and significantly shorten the duration of clinics. In addition, the United Kingdom Department of Health has been encouraging the use of anticoagulation services in Primary Care Trusts the aim being to provide INR monitoring in community clinics and General Practice surgeries relieving pressure on hospital services and reducing inconvenience for patients.
Although coagulometers are now commercially available the Microvisk INR Testing System has been designed to have advantages, particularly in terms of test robustness, user comfort, ease of use and reduction of user error. The present trial has been designed to develop the second generation Microvisk INR Test System; blood samples will also be used to optimise manufacturing processes and verify the quality of Test Strip Lots.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Merseyside
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Liverpool, Merseyside, Royaume-Uni, L7 8XP
- Recrutement
- Royal Liverpool & Broadgreen University Hospital NHS Trust
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Contact:
- Colin Downey
- Numéro de téléphone: +44 151 706 4322
- E-mail: Colin.Downey@rlbuht.nhs.uk
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Subject is male or female, greater than 18 years of age
- Subject is receiving warfarin (or warfarin-like) therapy as part of their clinical care
- Subject is informed and has been given ample time and opportunity to think about his/her participation and has given his/her written informed consent
Exclusion Criteria:
- Subjects aged <18 years of age
- Subjects who are unable to give written consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Warfarin Patients
Single Arm - blood collection by venepuncture in patients undergoing Warfarin Therapy
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Venepuncture to collect blood samples from Patients undergoing Warfarin Therapy.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The Primary Outcome will be measured in terms of differences in International Normalised Ratio when the Generation 2 system is tested against the Generation 1 system using the blood samples from the same donors.
Délai: 2 years
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The Primary Outcome will be measured in terms of differences in International Normalised Ratio when the Generation 2 system is tested against the Generation 1 system using the blood samples from the same donors.
Those differences will be reported in terms of accuracy, precision and sensitivity to interferents.
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2 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The Secondary Outcome will be measured in terms of differences in International Normalised Ratio when the Generation 2 system is tested against the International Standard Method using the blood samples from the same donors.
Délai: 2 years
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A master batch of test strips will be calibrated against an International Reference Preparation (rTF/09) thromboplastin.
The accuracy of the master batch will be verified using patient samples.
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2 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Cheng-Hock Toh, Professor, Royal Liverpool and Broadgreen University Hospital Trust
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RDE03
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