Optical-Based Blood Coagulation Profiling Device

基于光学的凝血分析仪

• 批准号: 8467239
• 负责人: Seemantini K Nadkarni
• 金额: $ 17.52万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8467239
• 关键词: Biological; Blood coagulation; Blood specimen; Care Technology Points; Child; Clinical Research; Coagulation Process; Defect; Devices; Enrollment; Human; Institutional Review Boards; Laboratories; Minority; Optics; Performance; Policies; Primary Health Care; Protocols documentation; Research; Research Project Grants; Specimen; Thrombelastography; United States National Institutes of Health; Woman; base; human subject; medical specialties; meetings

In the proposed research we will validate the performance of the OTEG devise on human blood samples. Discarded and de-identified excess human blood samples will be obtained from the MGH coagulation laboratory and from Biological Specialty Corp. (PA, USA). All specimens will be de-identified. Prior to the start of this study, an exempt human subjects protocol will be submitted for approval by the Partners IRB. Research that meets the criteria for Exemption 4 is not considered "clinical research" as defined by NIH. Therefore, the NIH policies for inclusion of women, minorities and children in clinical research, and targeted/planned enrollment tables, do not apply to research projects covered by Exemption 4.

在拟议的研究中，我们将验证OTEG装置对人体血液样本的性能。 将从MGH凝血中获得废弃和去识别的过量人血样本 实验室和来自Biological Specialty Corp.（PA，USA）。所有标本均将去除识别信息。开始前 在本研究中，将提交一份豁免人类受试者方案供Partners IRB批准。研究 符合豁免4标准的研究不被视为NIH定义的“临床研究”。因此 NIH将妇女、少数民族和儿童纳入临床研究的政策，以及有针对性/有计划的 注册表，不适用于豁免4所涵盖的研究项目。