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.
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Joseph Booth
- 电话号码:+44 845 956 9900
- 邮箱:joebooth@microvisk.com
学习地点
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Merseyside
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Liverpool、Merseyside、英国、L7 8XP
- 招聘中
- Royal Liverpool & Broadgreen University Hospital NHS Trust
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接触:
- Colin Downey
- 电话号码:+44 151 706 4322
- 邮箱:Colin.Downey@rlbuht.nhs.uk
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
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.
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
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.
大体时间: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
|
合作者和调查者
调查人员
- 学习椅:Cheng-Hock Toh, Professor、Royal Liverpool and Broadgreen University Hospital Trust
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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