Novel Broad-Spectrum Point-of-Care Coagulometer

新型广谱护理点凝血计

• 批准号: 10707617
• 负责人: Stefan Frank Zappe
• 金额: $ 106.88万
• 依托单位: PEROSPHERE TECHNOLOGIES INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10707617
• 关键词: Accident and Emergency department; Activated Partial Thromboplastin Time measurement; Address; Anticoagulants; Anticoagulation; Antiphospholipid Syndrome; Biological Assay; Blood; Blood Coagulation Disorders; Blood Platelets; Blood coagulation; Blood specimen; Caring; Citrates; Classification; Clinic; Clinical; Clinical Trials; Coagulation Process; Cytolysis; Detection; Development; Devices; Diagnostic; Disease; Documentation; Dose; Emergency Situation; Emergency treatment; Event; F8 gene; Factor V; Factor XI; Fibrin; Fibrinolytic Agents; Functional disorder; Future; Gene Mutation; Glass; Goals; Health Care Costs; Health Professional; Hemophilia A; Hemorrhage; Hospitals; Hyperhomocysteinemia; Inherited; Inpatients; Label; Light; Liver diseases; Low-Molecular-Weight Heparin; Manuals; Marketing; Measurement; Measures; Medical; Medical Device; Methods; Microfluidics; Monitor; Normal Range; Operative Surgical Procedures; Oral; Outcome; Outpatients; Pathway interactions; Patient Care; Patients; Pharmaceutical Preparations; Pharmacy facility; Phase III Clinical Trials; Physicians; Plasma; Point of Care Technology; Process; Protein C Deficiency; Protein S Deficiency; Prothrombin; Recombinants; Reference Values; Research; Risk; Sales; Sampling; Schedule; Scheme; Silicon; Surface; Surrogate Endpoint; Technology; Testing; Therapeutic; Thrombin; Time; Venous; Vitamin K Deficiency; Whole Blood; Work; biomarker development; clinical development; commercialization; fundamental research; gene therapy; healthy volunteer; improved; inhibitor; new technology; novel; patient screening; point of care; potential biomarker; response; restoration; routine care; temporal measurement; transmission process; volunteer; von Willebrand Disease

Project Summary/Abstract Work under this proposal supports development of a broad-spectrum point-of-care (POC) coagulometer by Perosphere Technologies (The Perosphere Technologies POC Coagulometer) with the intent to create and offer an automated, microfluidic version of the manual Lee/White clotting time method. The device is based on novel technology and utilizes reagent-less, single-use microfluidic cuvettes made of silicon and glass for measurement of blood samples. Clot activation occurs at the beginning of the intrinsic clotting pathway through contact of a blood sample with the inner glass and silicon surfaces of the cuvette. The device detects clot formation by monitoring the intensity of near-infrared light, transmitted through cuvette and blood sample, and sensing of fibrin assembly at the end of the common clotting pathway. The clot detection scheme affords development of two main assays, a Clotting Time Assay, that measures the time to onset of clot formation and is currently implemented on the coagulometer platform, and a Clot Lysis Time assay, that measures the time to onset of subsequent clot breakdown and is in development. Research indicates that the device is broadly sensitive to the effects of anticoagulants across drug class, their reversal agents and thrombolytic drugs. Initial marketing efforts will focus on use of the device with implemented Clotting Time assay for monitoring of the direct oral anticoagulants (DOACs) and low molecular weight heparins (LMWHs). Research under this proposal targets establishment of clotting time reference ranges for healthy volunteers and patients on the DOACs rivaroxaban, apixaban, dabigatran and edoxaban, in direct support of initial marketing goals. In support of future device applications, the research also targets assessment of the device’s ability to detect inherited or acquired coagulopathies, based on abnormal clotting times, as well as assessment of the device’s sensitivity to abelacimab, a novel anticoagulant and direct factor XI/XIa inhibitor, currently in clinical development. Perosphere Technologies intends to commercialize the device through a marketing, sales and distribution partnership with a global medical device company. The device is similarly suited for use in emergency situations (e.g. emergency room, emergency vehicle) and for routine care in the inpatient and outpatient settings (hospitals, clinics, surgical suites, doctor’s offices, pharmacies) by healthcare professionals who can perform or order fresh venous whole blood draws. The device promises to address several unmet medical needs, including point-of- care monitoring of DOACs, and has the potential to define new standards of care. The device is expected to improve patient care, clinical outcome and to reduce healthcare costs, by providing physicians with the means to make faster and better-informed treatment decisions. The developed Clotting Time and Clot Lysis Time assays will present a new way to describe a patient’s coagulation state and enable opportunities for fundamental research of disease mechanisms and therapeutic approaches.

项目概要/摘要 该提案下的工作支持通过以下方式开发广谱床旁 (POC) 凝血计 Perosphere Technologies（Perosphere Technologies POC 凝血计）旨在创建和提供 手动 Lee/White 凝血时间方法的自动化微流体版本 该设备基于新颖的技术。 技术并利用由硅和玻璃制成的无试剂、一次性微流体比色皿进行测量 血液样本的凝块激活发生在内在凝血途径的开始时，通过接触 该装置通过比色皿的内玻璃和硅表面检测血样的凝块形成。 监测通过比色皿和血液样本传输的近红外光的强度，并感测纤维蛋白 凝块检测方案提供了两种方法的开发。 主要检测是凝血时间检测，可测量凝块形成开始的时间，目前正在研究中 在凝血计平台上实施，以及血块溶解时间测定，测量测定开始的时间 随后的凝块分解并且正在开发中 研究表明该设备对以下物质广泛敏感。 不同药物类别的抗凝剂、其逆转剂和溶栓药物的影响。 将重点关注使用该设备并实施凝血时间测定来监测直接口服 该提案的研究目标是抗凝剂（DOAC）和低分子肝素（LMWH）。 为使用 DOAC 利伐沙班的健康志愿者和患者建立凝血时间参考范围， 阿哌沙班、达比加群和艾多沙班，直接支持最初的营销目标 支持未来的设备。 应用程序，该研究还旨在评估设备检测遗传或获得性的能力 凝血病，基于异常凝血时间，以及设备的敏感性评估 abelacimab 是一种新型抗凝剂和直接 XI/XIa 因子抑制剂，目前正处于临床开发阶段。 Perosphere Technologies 打算通过营销、销售和分销将该设备商业化 该设备同样适合在紧急情况下使用。 （例如急诊室、急救车辆）以及住院和门诊环境（医院、 诊所、手术室、医生办公室、药房）由医疗保健专业人员执行或订购新鲜的 该设备有望解决一些未满足的医疗需求，包括现场抽血。 DOAC 的护理监测，并有可能定义新的护理标准。 通过为医生提供手段来改善患者护理、临床结果并降低医疗成本 制定更快、更明智的治疗决策。 检测将提供一种描述患者凝血状态的新方法，并为基础研究提供机会 疾病机制和治疗方法的研究。