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500万美国患者每天服用口服抗凝剂以预防和治疗 血栓栓塞事件。其中大多数是需要频繁在家监测抗凝剂的门诊病人 治疗。根据预防国家不良药物事件（ADE）的国家行动计划，抗凝剂是“最多的 跨卫生保健环境中AD的常见原因”。老年人的所有紧急住院中有33％是 意外抗凝剂过量的结果。但是目的地这些抗凝治疗中的这些重大问题 管理，可用的家庭使用设备，用于口服抗凝治疗的设备不仅是不良的预测因素 凝血状态，但也不对口服抗凝剂的剂量作用敏感。 该SBIR I期项目的长期目标是开发一种原型设备，以进行家庭使用监视 抗凝治疗。 Levisonics Inc.开发了一种独特的实验室技术来进行血液凝血分析， 被称为“准静态声学镊子血栓栓塞术”或QATT。在Qatt中，克隆的暂时变化 从一滴血液（体积的4-6微晶）中评估牢固度 力量。 Qatt通过以下破坏性特征解决了家庭护理凝血测试的问题：1） 小样本量要求； 2）由于非接触式测量而引起的可靠性和准确性提高； 3）快速 评估血液凝血状态。 该SBIR提案的目的将在三个任务中完成。首先，现有的实验室研究 设备将被微型化并精制成适合家庭使用的外形（特定AIM 1），并具有简化的用户 目标人群的界面。其次，将实施一种手指到设备样本输送方法（具体 目标2）仅需要一根手指滴血。第三，房屋的可行性在 特定目标1将通过测试正常志愿者的毛细血管和静脉血来确定（特定目标3） 暴露于肝素和口服抗凝剂剂量的受控变化。