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.

项目摘要/摘要 根据该提案的工作支持开发广谱的护理点（POC）凝结仪 旨在创建和提供的外圈技术（po圈技术POC凝结仪） 手动Lee/White关闭时间方法的自动，微流体版本。该设备基于新颖 技术并利用由硅和玻璃制成的无试剂单利用的微流体比例 血液样本。凝块激活发生在固有服装途径的开头，通过接触 带有比色杯的内部玻璃和硅表面的血液样品。该设备通过 监测近红外光的强度，通过比色杯和血液样本传播，以及纤维蛋白的敏感性 在公共关闭途径末端的组装。凝块检测方案提供了两个 主要测定是一种凝结时间测定，该测定时间衡量了凝块形成的时间，目前是 在凝结计平台上实施，以及一个凝结裂解时间测定法，该测定时间衡量了发作的时间 随后的凝块分解并正在开发中。研究表明该设备对 药物类别，逆转剂和溶栓药物的抗凝剂的影响。最初的营销 努力将集中于使用该设备和实施的凝结时间测定，以监视直接口服 抗凝剂（DOAC）和低分子量肝素（LMWHS）。根据该提案的目标进行研究 在DOACS Rivaroxaban上为健康志愿者和患者建立关闭时间参考范围， Apixaban，Dabigatran和Edoxaban直接支持初始营销目标。支持将来的设备 应用程序，该研究还针对对设备检测遗传或获取的能力的评估 凝血病，基于异常关闭时间，并评估设备对 Abelacimab是一种新型抗凝剂和直接因子XI/XIA抑制剂，目前正在临床发育中。 上圈技术打算通过营销，销售和分销商业化设备 与全球医疗设备公司合作。该设备同样适合在紧急情况下使用 （例如急诊室，急诊车），并在住院和门诊环境中进行常规护理（医院， 医疗保健专业人员的诊所，外科套房，医生办公室，药房），他们可以表演或订购新鲜 静脉全血。该设备有望满足几种未满足的医疗需求，包括 对DOAC的护理监测，并有可能定义新的护理标准。该设备有望 通过为医生提供手段，改善患者护理，临床结果并降低医疗保健成本 做出更快，更有信息的治疗决策。发达的凝血时间和凝块裂解时间 测定将提出一种描述患者凝血状态的新方法，并为基本的机会提供机会 研究疾病机制和治疗方法。