NONINSTRUMENTED, RAPID, QUANTITATIVE BLOOD HEPARIN ASSAY

非仪器、快速、定量血肝素测定

• 批准号: 3502369
• 负责人: JAMES C MC REA
• 金额: $ 5万
• 依托单位: RESEARCH MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-02-01 至 1993-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3502369
• 关键词: biomaterial evaluation; blood coagulation; blood coagulation tests; chemical binding; diagnosis design /evaluation; heparin; human tissue; patient monitoring device; postoperative state; rapid diagnosis

Currently, in the clinical setting of open heart surgery, several anticoagulation assays are used to monitor heparin therapy. While these methods for monitoring heparin are effective, they require eight to ten minutes or more to run, several steps of blood handling, as well as instruments to make an end point reading. Also, these current assays only indicate a biological response and provide, at best, an indirect quantitative measure of heparin. With over 350,000 open heart procedures per year in the U.S., where high dose heparin is administered and must subsequently be reversed, the need for rapid, low cost, quantitative assay for blood heparin is well recognized. It is the overall goal of the proposed work to develop a diagnostic assay that will accurately measure the amount of heparin in an accurate, quick (less than 1-2 min.) and cost effective fashion. A novel feature of the proposed heparin assay is that even relatively high heparin concentrations would not necessarily require greater time for testing. By the end of Phase 1, a prototype assay will be tested against standard laboratory assays utilizing fresh collected blood bank blood to characterize correlation coefficients amongst heparin assays in the Phase 11 studies. Preliminary in vitro tests show that clot formation times can be reduced by 35% to 50%; greater reduction can be expected.

目前，在心脏病手术的临床环境中，有几个 抗凝测定用于监测肝素治疗。 而这些 监测肝素的方法有效，它们需要八到十 几分钟或更长时间，几个步骤的血液处理以及 进行终点读数的仪器。 另外，这些当前的测定 仅表示生物学反应并充其量提供间接 肝素的定量度量。 超过350,000个开放心脏手术 每年在美国进行高剂量肝素，必须 随后被逆转，需要快速，低成本，定量 血液肝素的测定众所周知。 这是拟议工作的总体目标是开发诊断测定法 这将准确地测量准确，快速的肝素数量 （不到1-2分钟）和成本效益的时尚。 一个新颖的特征 提出的肝素测定是，甚至相对较高的肝素 浓度不一定需要更大的测试时间。 到第1阶段结束时，将针对标准测试原型测定 利用新鲜收集的血库血液到实验室测定 表征相关系数中肝素测定中的相关系数 11研究。 初步的体外测试表明可以减少凝块形成时间 在35％至50％上；可以预期更大的减少。