Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648837
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Microvisk Continuous Blood Donation Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Continuous Blood Donation for the Development of the Microvisk PTINR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Microvisk Technologies Ltd designs and develops test systems for monitoring the effectiveness of Warfarin and Warfarin-like medications
Warfarin and Warfarin-like medications are used to reduce the risk of stroke in people with an irregular heart rhythm Atrial Fibrillation or with mechanical heart valve replacements as well as reducing the risk of recurrent Venous Thromboembolism
Warfarin dosing needs to be individualized In order to correctly dose an individual in order to optimize the effectiveness of warfarin and minimize the risk of bleeding close monitoring of the degree of anticoagulation is required through regular blood testing This test is known as PTINR Prothrombin TimeInternational Normalised Ratio Simply it is the measure of the amount of time in seconds it takes for your blood to clot
Microvisk Technologies Ltd are developing new anticoagulant test strips for patients on warfarin or warfarin like medications The blood collected as part of this study will be tested upon Microvisks second generation ProthrombinInternational Normalized Ratio PTINR Test System The donated blood will be used on ongoing development validation verification and calibration projects This study is being performed in partnership with the Oxford University Hospital OUH and Local Clinical Research Networks LCRN Thames Valley Core team part of National Institute for Health and Care Research NIHR
Warfarin and Warfarin-like medications are used to reduce the risk of stroke in people with an irregular heart rhythm Atrial Fibrillation or with mechanical heart valve replacements as well as reducing the risk of recurrent Venous Thromboembolism
Warfarin dosing needs to be individualized In order to correctly dose an individual in order to optimize the effectiveness of warfarin and minimize the risk of bleeding close monitoring of the degree of anticoagulation is required through regular blood testing This test is known as PTINR Prothrombin TimeInternational Normalised Ratio Simply it is the measure of the amount of time in seconds it takes for your blood to clot
Microvisk Technologies Ltd are developing new anticoagulant test strips for patients on warfarin or warfarin like medications The blood collected as part of this study will be tested upon Microvisks second generation ProthrombinInternational Normalized Ratio PTINR Test System The donated blood will be used on ongoing development validation verification and calibration projects This study is being performed in partnership with the Oxford University Hospital OUH and Local Clinical Research Networks LCRN Thames Valley Core team part of National Institute for Health and Care Research NIHR
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None