Drop-of-blood technology for home-use monitoring of anticoagulant therapy

用于家庭抗凝治疗监测的滴血技术

• 批准号: 10187996
• 负责人: Nithya Kasireddy
• 金额: $ 22.52万
• 依托单位: LEVISONICS, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10187996
• 关键词: Acoustics; Activated Partial Thromboplastin Time measurement; Address; Adverse drug event; Affect; Air; Anticoagulant therapy; Anticoagulants; Anticoagulation; Atrial Fibrillation; Blood; Blood Coagulation Factor; Blood Volume; Blood capillaries; Blood coagulation; Blood specimen; COVID-19 patient; Cause of Death; Coagulation Factor Deficiency; Coagulation Process; Data; Detection; Devices; Diagnostic; Dose; Drops; Elderly; Event; Exposure to; Fibrinogen; Fibrinolysis; Fibrinolytic Agents; Fingers; Goals; Healthcare Systems; Heart Diseases; Heart Valve Diseases; Hemorrhage; Hemostatic Agents; Heparin; Home; Hospitalization; Hospitals; Individual; Laboratory Research; Lead; Measurement; Measures; Medicine; Methods; Monitor; Motor; Oral; Outcome; Outpatients; Overdose; Patients; Pharmaceutical Preparations; Phase; Plasma; Prevention; Procedures; Radiation; Recurrence; Reporting; Retirement; Risk; Sampling; Small Business Innovation Research Grant; Target Populations; Technology; Testing; Thromboembolism; Time; Update; Variant; Veins; Venipunctures; Venous; Venous Thrombosis; Venous blood sampling; Visit; Visual; Warfarin; Wireless Technology; Work; aging population; base; cost; data standards; dosage; health care settings; healthy volunteer; home test; inhibitor/antagonist; injured; innovation; miniaturize; monitoring device; novel; older patient; platelet function; point of care; prototype; response; safety testing; sample collection; volunteer

PROJECT SUMMARY More than 5 million U.S. patients take oral anticoagulants daily for the prevention and treatment of thromboembolic events. Most of them are outpatients in need of frequent at‐home monitoring of anticoagulant therapy. According to the National Action Plan for Adverse Drug Event (ADE) Prevention, anticoagulants are “the most common causes of ADEs across health care settings”. 33% of all emergent hospitalizations among older adults are the result of unintentional anticoagulant overdose. Yet despite these significant problems in anticoagulation therapy management, available devices for home‐use monitoring of oral anticoagulant therapy are not only poor predictors of coagulation status, but also not sensitive to dosage effects of oral anticoagulants. The long‐term objective of this SBIR Phase I project is to develop a prototype device for home‐use monitoring of anticoagulant therapy. Levisonics Inc. has developed a unique lab‐in‐a‐drop technology for blood coagulation analysis, referred to as “quasi‐static acoustic tweezing thromboelastometry” or QATT. In QATT, temporal changes in clot firmness are assessed from a single drop of blood (4‐6 microliters in volume) levitating in air under the acoustic radiation force. QATT addresses the issues of home point‐of‐care coagulation testing through the following disruptive features: 1) small sample volume requirement; 2) increased reliability and accuracy due to non‐contact measurement; and 3) rapid assessment of blood coagulation status. The objective of this SBIR proposal will be accomplished in three tasks. First, the existing laboratory research apparatus will be miniaturized and refined to a form factor suitable for home use (Specific Aim 1), with a simplified user interface for the target population. Second, a finger‐to‐device sample delivery method will be implemented (Specific Aim 2) requiring only a single finger‐prick drop of blood. Third, the feasibility of the home use prototype developed in Specific Aim 1 will be established by testing both capillary and venous blood from normal volunteers (Specific Aim 3) exposed to controlled variations of heparin and oral anticoagulant doses.

项目摘要 超过500万的美国患者每天服用口服抗凝剂来预防和治疗 血栓栓塞事件。其中大多数是门诊患者，需要经常在家监测抗凝剂 疗法根据国家药物不良事件（ADE）预防行动计划，抗凝剂是“最 医疗机构中ADE的常见原因”。33%的老年人紧急住院治疗是 意外抗凝剂过量的结果。尽管抗凝治疗存在这些重大问题， 管理，可用的家用监测口服抗凝剂治疗的设备不仅是不良的预测因子， 凝血状态，但对口服抗凝剂的剂量效应也不敏感。 SBIR第一阶段项目的长期目标是开发一种家用监测原型设备， 抗凝治疗Levisonics Inc.开发了一种独特的用于血液凝固分析的点滴实验室技术， 称为“准静态声学镊子血栓弹性测定法”或QATT。在QATT中，凝块的时间变化 通过在声辐射下悬浮在空气中的单滴血液（体积为4 - 6微升）评估硬度 力QATT通过以下破坏性功能解决家庭床旁凝血测试问题：1） 小的样品体积要求; 2）由于非接触式测量，提高了可靠性和准确性; 3）快速 评估凝血状态。 本SBIR提案的目标将通过三项任务来实现。一、现有实验室研究 设备将被小型化和改进为适合家庭使用的形状因子（具体目标1），具有简化的用户 目标人群的界面。其次，将实施手指到器械样本递送方法（具体 目的2）只需要一个手指刺血滴。第三，家庭使用的原型开发的可行性， 将通过检测正常志愿者的毛细血管和静脉血确定特定目标1（特定目标3） 暴露于肝素和口服抗凝剂剂量的受控变化。