A NOVEL POINT-OF-CARE PLATELET FUNCTION ANALYZER

新型护理点血小板功能分析仪

• 批准号: 7090791
• 负责人: Don B. Olsen
• 金额: $ 95.7万
• 依托单位: THROMBODYNE, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-11-01 至 2008-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7090791
• 关键词: biomedical equipment development; cell component structure /function; clinical biomedical equipment; clinical research; clinical trials; human subject; lasers; light scattering; measurement; patient oriented research; platelet activation; platelet aggregation; platelet disorder

DESCRIPTION (provided by applicant): Coronary heart disease (CHD) and stroke remain 1 of the major causes of morbidity and mortality in the US, and platelets play a major role in CHD/stroke. Thus, the use of antiplatelet drugs is helpful in the prevention or treatment of such vascular disorders. Despite routine use of antiplatelet agents in a large number of patients, the efficacy of antiplatelet therapy is rarely monitored in each patient. Most patients are prescribed a fixed dose with no effort to establish therapeutic efficacy, and the lack of suitable strategies precludes individual monitoring and adjustment of dosage to ensure adequate protection. The need for monitoring antiplatelet therapy is further accentuated by the fact that as many as 30% of patients may be resistant to standard dosages of commonly used antiplatelet drugs such as aspirin and clopidogrel. The current methods for the assessment of platelet function are cumbersome and time-consuming (laboratory methods), or relatively expensive, unreliable and offer only an indirect/incomplete measure (current point-of care instruments), and therefore lack sensitivity. Thrombodyne Inc. has developed, with funding from NIH, a novel approach to assess platelet function in whole blood. A functional version of the Thrombodyne Platelet Function Analyzer (TPFA) has withstood the rigors of laboratory and limited clinical testing, and detects platelet function abnormalities and identifies patients who may be resistant to standard doses of antiplatelet agents. Through this application, the investigators request support to sustain their efforts to: 1) make TPFA a cost-effective, convenient and versatile point-of-care instrument, 2) to seek FDA approvals to prepare it for marketing, and 3) to demonstrate that individually tailored dosing of antiplatelet agent (or combination of agents) would lead to better therapeutic efficacy, reduce side effects, and result in better outcomes. The applicants are at a unique point in their development path where the requested funding would allow them to take the device to market. The introduction of this convenient, cost-effective point-of-care platelet function analyzer would make it possible to tailor antiplatelet therapy for each individual and improve outcomes.

描述（由申请人提供）：冠状动脉疾病（CHD）和中风仍然是美国发病和死亡率的主要原因，而血小板在CHD/中风中起着重要作用。因此，使用抗血小板药物有助于预防或治疗这种血管疾病。尽管在大量患者中常规使用抗血小板药，但很少监测每位患者抗血小板治疗的功效。大多数患者的处方固定剂量没有努力确定治疗功效，并且缺乏合适的策略阻止了个人监测和调整剂量以确保适当的保护。监测抗血小板治疗的需求进一步强调了以下事实：多达30％的患者可能对常见使用的抗血小板药物（如阿司匹林和氯吡格雷）具有抵抗力。当前评估血小板功能的方法是繁琐且耗时的（实验室方法），或者相对昂贵，不可靠，并且仅提供间接/不完整的度量（当前的医疗点工具），因此缺乏灵敏度。 Thrombody Inc.在NIH的资金中开发了一种新型方法，用于评估全血的血小板功能。 Thrombody血小板功能分析仪（TPFA）的功能版本具有严格的实验室和有限的临床测试，并检测到血小板功能异常，并鉴定出可能抗标准剂量抗血小板药物的患者。通过此应用，调查人员要求支持他们的努力：1）使TPFA成为一种经济高效，方便和多功能的护理工具，2）寻求FDA批准以为营销做好准备，3）证明，单独量身定制的抗血小板剂（或组合剂的组合）会导致更好的效果，从而使副作用更好地效应，从而使效应效果更好。申请人处于其开发路径中的独特点，所要求的资金将使他们能够将设备推向市场。引入这种方便的，具有成本效益的护理点血小板功能分析仪将使每个人都可以量身定制抗血小板疗法并改善预后。