DEVELOPMENT OF A WHOLE-BLOOD PLATELET AGGREGOMETER

全血血小板聚集仪的开发

• 批准号: 6298960
• 负责人: SYED F MOHAMMAD
• 金额: $ 38.05万
• 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 2003-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6298960
• 关键词: biomedical equipment development; cell component structure /function; human subject; lasers; light scattering; measurement; platelet activation; platelet aggregation; platelet disorder

DESCRIPTION (Verbatim From Applicant's Abstract):This phase II application is for further development, optimization, and clinical testing of a platelet function assay called the light scattering whole blood aggregometer (LSWBA). The concept of utilizing differential light scattering for the detection of platelet aggregates in whole, undiluted blood was proven as part of Phase I research. Further, when the LSWBA was compared with the existing laboratory-based aggregometers, the results documented that the assessment of platelet function with LSWBA was qualitatively similar to the existing devices. The most stifling limitation of the platelet aggregometers currently on the market is that blood samples have to be sent to the laboratory for the assessment of platelet function. Assessment of platelet function at the point of care may greatly improve antiplatelet therapy by providing clinicians the opportunity to tailor drug regimen to suit individual patient needs. The LSWBA addresses all the logistical and conceptual limitations of the existing devices and is poised to emerge as a true bedside diagnostic tool for the assessment of platelet function. The availability of such a device will enable physicians to fine-tune drug therapy and to minimize the risk of thrombosis or bleeding. The Phase II work is proposed to: 1) further optimize and standardize the sample holder which is an essential part of the LSWBA, 2) establish a databank of agonist dose-responses to later identify abnormal platelet function and, 3) test the point-of care utility of the LSWBA in the clinical environment. PROPOSED COMMERCIAL APPLICATION: This research will lead to a prototype point-of-care diagnostic tool to assess platelet function. This tool will permit physicians to tailor prophylactic and therapeutic antiplatelet drug regimen in a manner that was not possible before. A more controlled antiplatelet therapy will not only minimize the risk of adverse effects but will also reduce patient morbidity and will result in an overall improved clinical outcome. Current estimates suggest a market potential of approximately $100 million/year for equipment and supplies for a point-of-care whole blood aggregometer.

描述（逐字从申请人的摘要）：这第二阶段的申请是 用于血小板的进一步开发、优化和临床测试 功能测定称为光散射全血凝集仪（LSWBA）。 利用差分光散射检测的概念， 在整个未稀释的血液中的血小板聚集被证明是I期研究的一部分， research.此外，当LSWBA与现有的 实验室为基础的聚集计，结果证明，评估 LSWBA的血小板功能在性质上与现有装置相似。 目前血小板聚集仪最令人窒息的限制是 血液样本必须被送到实验室， 评估血小板功能。血小板功能评估 通过为临床医生提供 有机会定制药物方案，以满足个别患者的需求。LSWBA 解决了现有设备的所有逻辑和概念限制 并有望成为一个真正的床边诊断工具，用于评估 血小板功能这种设备的可用性将使医生能够 微调药物治疗，并尽量减少血栓形成或出血的风险。的 第二阶段工作拟： 1)进一步优化和标准化样品保持器， LSWBA的一部分，2）建立激动剂剂量反应数据库， 识别异常的血小板功能，以及3）测试以下的护理点效用： 临床环境中的LSWBA。 拟定商业应用： 这项研究将导致一个原型的即时诊断工具，以评估血小板功能。 该工具将允许医生定制预防性和治疗性抗血小板药物方案 这在以前是不可能的。 一个更受控制的抗血小板治疗不仅 最大限度地降低不良反应的风险，但也将降低患者的发病率，并将导致 总体改善临床结局。 目前的估计表明，市场潜力约为 1亿美元/年，用于护理点全血聚集仪的设备和用品。