Development of New-Generation Thrombelastograph (R)

描述(由申请人提供)：每年有近200万人因缺血事件住院。为了将复发的风险降到最低，几乎所有的患者都开了阿司匹林或其他抗血小板治疗，86%的患者在出院时开了抗凝剂。抗凝和抗血小板治疗需要经常监测，以降低出血或血栓形成的风险。抗凝监测的常规做法导致每年7-8%的患者出现大出血，血栓栓子事件的发生率也相似。当患者在较长时间内保持在治疗范围内时，通过重点护理点(POC)监测，这些不良事件可减少约50%或更多。 血栓弹力仪。(Teg.)5000型止血系统用于测量患者止血的所有阶段和状态，包括血栓前状态。TEG 5000是一种台式实验室仪器，也可以在POC使用。然而，尽管该系统在临床和商业上取得了成功，但其配置排除了在医院内外的一些PoC地点普遍使用的可能性。样本的大小和测试的复杂性要求人员能够进行静脉采血，能够进行吸管，并且接受过QC和其他实验室程序的培训。为了将该系统的使用扩大到医生办公室，并允许进行缺血风险的筛查和抗凝和抗血小板治疗的监测，需要一种紧凑、便携、易于使用的仪器。血液镜正在设计这样一种新一代POC仪器，用于按需监测患者的止血。该仪器将引入一种全新的凝血监测技术，非常适合从医院内到门诊护理诊所、医生办公室和病人家中的整个护理过程。我们相信，这样的设备，无论设备位置或操作人员，都能产生及时和同等的结果，可以显著提高血栓前患者的护理标准，改善临床结果。在护理点(POC)监测凝血已导致更好的患者结果和更少的并发症。这笔赠款建议开发一种新型号的血栓弹力仪。(Teg.)止血系统(TEG 6500)，结合了一种新的方法，用于监测凝块形成和溶解期间的粘弹性特性。这种设备适合在医院内外使用，包括病人家中。由于TEG系统具有捕捉凝血全过程的独特能力，已被证明在监测和预测住院患者的止血风险方面是有益的，当推出更小、更易于使用和更便宜的型号时，TEG系统将可以在医院外使用。这将提供在医生办公室、诊所或其他服务点地点筛查心脏病发作、中风等风险的能力。

DESCRIPTION (provided by applicant): Nearly 2 million people are hospitalized each year for ischemic events. To minimize the risk of recurrent events, nearly all patients are prescribed aspirin or other antiplatelet therapy and 86% are prescribed anticoagulants upon discharge. Anticoagulation and antiplatelet therapy requires frequent monitoring to reduce the risks of bleeding or thrombosis. The usual practice of anticoagulation monitoring has resulted in a major hemorrhage in 7-8% of patients per year of therapy and a similar rate of thromboembolic events. These adverse events are reduced by about 50% or more with focused point of care (POC) monitoring when patients are maintained in the therapeutic range for longer periods of time. The Thrombelastograph . (TEG.) Model 5000 Hemostasis System is used to measure all phases and states of patient hemostasis, including a prothrombotic state. The TEG 5000 is a bench-top laboratory instrument that can also be used at POC. However, despite the clinical and commercial success of the system, its configuration precludes general use in some POC locations within and outside the hospital. The sample size and testing complexity require personnel who can perform phlebotomy, are able to pipette, and who are trained in QC and other lab procedures. To expand the use of the system to physician offices and allow accessible screening for ischemic risk and monitoring of anticoagulation and antiplatelet therapy, a compact, portable, easy to use instrument is needed. Haemoscope is designing such a new-generation POC instrument for monitoring patient hemostasis on demand. The instrument will introduce a completely new technology for monitoring coagulation one well suited for use across the continuum of care from inside the hospital, to ambulatory care clinics, physician offices and patient homes. We believe such a device, one which produces timely and equivalent results regardless of device location or operator, can substantially enhance the standard of care for prothrombotic patients and improve clinical outcomes.Monitoring blood coagulation at the point-of-care (POC) has resulted in better patient outcomes and fewer complications. This grant proposes the development of a new model of the Thrombelastograph. (TEG.) Hemostasis System (TEG 6500), incorporating a novel approach for monitoring the viscoelastic properties of clots during formation and lysis. This device would be appropriate for use inside and outside the hospital, including patient homes. Because of its unique ability to capture the entire profile of coagulation, the TEG system has proven beneficial in monitoring and predicting hemostasis risk in hospitalized patients and will be accessible outside the hospital when a smaller, easier-to-user, and less expensive model is available. This will provide the capability to screen for risk of heart attack, stroke, etc., in the physician's office setting, or in clinics or other point of service locations.