Wearable Microchip for Assessing Global Hemostatsis

用于评估整体止血的可穿戴微芯片

• 批准号: 10379325
• 负责人: David Richard Myers
• 金额: $ 15.75万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-03-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10379325
• 关键词: Activated Partial Thromboplastin Time measurement; Agreement; Anticoagulants; Biological Assay; Bleeding time procedure; Blood; Blood Cells; Blood Coagulation Disorders; Blood Coagulation Factor; Blood Platelets; Blood Volume; Blood flow; Blood specimen; Cells; Childhood; Clinic; Clinical; Clinical Research; Coagulation Process; Complement; Complex; Consumption; Data; Devices; Diagnosis; Diagnostic; Disease; Engineering; Environment; Expert Opinion; Forearm; Gold; Health Expenditures; Hemophilia A; Hemophilia B; Hemorrhage; Hemostatic Agents; Hemostatic function; Heparin; In Situ; In Vitro; Individual; Institution; Intuition; K-Series Research Career Programs; Lead; Life; Measurement; Measures; Medicine; Mentors; Microfabrication; Microfluidics; Morbidity - disease rate; Oral; Paper; Patient Monitoring; Patients; Phenotype; Physicians; Platelet aggregation; Plavix; Population; Proteins; Prothrombin time assay; Research; Sampling; Savings; Skin; Standardization; Supervision; Surface; System; Testing; Therapeutic; Thrombosis; Time; Tissues; Training; Translating; Translational Research; Universities; Variant; Warfarin; analog; base; care costs; career development; clinical practice; clinically relevant; cost; diabetic; experience; experimental study; flexible electronics; fundamental research; improved; in vivo; in vivo evaluation; innovation; microchip; microdevice; microelectronics; miniaturize; mortality; new technology; novel; pediatric patients; percutaneous coronary intervention; platelet function; point of care; prototype; research clinical testing; response; screening; sensor; tool; trend; vasoconstriction; wound

PROJECT SUMMARY Bleeding and thrombosis are common and lethal complications of many disease states. However, answering the simple question “Is this patient in danger of abnormal bleeding or clotting?” in a timely manner remains challenging with the existing clinical tests, which are time consuming and prone to error via the introduction of pre-analytical variables. Importantly, no test assess vasoconstriction or the overall entire hemostatic response, which is composed of concerted actions between platelets, cells, coagulation proteins, and the tissue/vessel complex. In addition, the response is unique to each individual and difficult to predict. Hence, given delays and limited information, it is unsurprising that physicians rely on expert opinion rather than the existing panel of tests in complicated clinical situations. The research objective of this proposal is to apply the nascent fields of flexible electronics and microfluidics to create a wearable, multi-parameter, point of care (POC), rapid, and comprehensive assessment of hemostasis that helps physicians diagnose and manage hemostatic complications. I hypothesize that a wearable microchip-based device that completely automates the bleeding time assay and adds POC analogs of existing tests will create a quantitative, reliable, and comprehensive measurement of hemostasis. I will apply advanced engineering tools to automatically collect and measure blood from a standardized, small wound created on the volar forearm surface with a typical diabetic lancet. Specific Aim 1 focuses on in vitro and in vivo clinical testing of an automated wound hemostasis assay that measures the overall and complete hemostatic response, including vasoconstriction. Specific Aim 2 slightly reconfigures the platform in aim 1, to enable quantitative measurements of 1) coagulation function which is analogous to prothrombin time (PT), 2) activated partial thromboplastin time (aPTT); and 3) platelet function which is analogous to a platelet functional analyzer (PFA). Specific Aim 3 tests the acceptability of the new technology in pediatric patients and examines the reliability (or degree of agreement) of the POC aPTT to the lab based aPTT for patients being anticoagulated with heparin. The aims outlined here lay the groundwork for a device that will transform clinical practice by providing critical information to diagnose and guide the management of hemostatic complications that ultimately will reduce the significant morbidity and cost of altered hemostasis. In addition, the career development activities complement the candidate’s micro-engineering background with formal coursework and supervised training in translational research fundamentals, coagulation, and conducting clinical research with novel biomedical devices. This training occurs in a highly interdisciplinary and innovative environment created by institutions with strengths in micro-engineering (Georgia Tech) and medicine (Emory University). Upon completion, the candidate will able to independently translate microdevices from the cleanroom to the clinic.

项目总结