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）：冠心病 (CHD) 和中风仍然是美国发病和死亡的主要原因之一，而血小板在 CHD/中风中发挥着重要作用。因此，使用抗血小板药物有助于预防或治疗此类血管疾病。尽管大量患者常规使用抗血小板药物，但很少对每位患者进行抗血小板治疗的疗效监测。大多数患者被开出固定剂量，但没有努力确定治疗效果，并且缺乏合适的策略妨碍了个体监测和剂量调整以确保充分的保护。由于多达 30% 的患者可能对阿司匹林和氯吡格雷等常用抗血小板药物的标准剂量产生耐药性，这一事实进一步凸显了监测抗血小板治疗的必要性。目前评估血小板功能的方法繁琐且耗时（实验室方法），或者相对昂贵、不可靠并且仅提供间接/不完整的测量（当前的护理点仪器），因此缺乏敏感性。 Thrombodyne Inc. 在 NIH 的资助下开发了一种评估全血中血小板功能的新方法。凝血酶体血小板功能分析仪 (TPFA) 的功能版本经受住了严格的实验室和有限的临床测试，可检测血小板功能异常并识别可能对标准剂量的抗血小板药物产生耐药性的患者。通过此申请，研究人员请求支持以维持他们的努力：1) 使 TPFA 成为具有成本效益、方便且多功能的即时护理工具，2) 寻求 FDA 批准以准备上市，以及 3) 证明单独定制的抗血小板药物（或药物组合）剂量将带来更好的治疗效果，减少副作用，并产生更好的结果。申请人正处于其开发道路上的一个独特阶段，所请求的资金将使他们能够将设备推向市场。这种方便、经济高效的即时血小板功能分析仪的推出将使为每个人量身定制抗血小板治疗并改善结果成为可能。