Development of New-Generation Thrombelastograph (R)

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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.