- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02355730
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Joseph Booth
- Telefonnummer: +44 845 956 9900
- E-post: joebooth@microvisk.com
Studieorter
-
-
Merseyside
-
Liverpool, Merseyside, Storbritannien, L7 8XP
- Rekrytering
- Royal Liverpool & Broadgreen University Hospital NHS Trust
-
Kontakt:
- Colin Downey
- Telefonnummer: +44 151 706 4322
- E-post: Colin.Downey@rlbuht.nhs.uk
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Warfarin Patients
Single Arm - blood collection by venepuncture in patients undergoing Warfarin Therapy
|
Venepuncture to collect blood samples from Patients undergoing Warfarin Therapy.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
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.
Tidsram: 2 years
|
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.
|
2 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
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.
Tidsram: 2 years
|
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.
|
2 years
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Cheng-Hock Toh, Professor, Royal Liverpool and Broadgreen University Hospital Trust
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RDE03
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