Development Of A Next-Generation Thrombelastograph

DESCRIPTION (provided by applicant): Coramed is designing a next-generation point-of-care (POC) instrument, the TEG 6500, for monitoring patient hemostasis on demand. The instrument will introduce a completely new technology for monitoring clot formation and breakdown that is well suited for the continuum of settings 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. The TEG 6500 will be the successor to the widely accepted Thrombelastograph (R) (TEG(R)) Model 5000 Hemostasis System - 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 inside the hospital and in any locations 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 such as the TEG 6500 is needed. PUBLIC HEALTH RELEVANCE: 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(R) (TEG(R)) 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 home monitoring of patients. As a result 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. This capability will reach a market outside hospital labs when a more robust, easier-to-use, and less expensive model is available. The result will be the capability to screen for risk of heart attack and stroke in the physician's office setting, or in clinics and other point of service locations.