Miniature, Portable, Device to Detect and Monitor Coagulopathy

Trauma is a leading cause of both military and civilian mortality, accounting for roughly 10% of all deaths worldwide. Coagulopathy (disturbance of the physiologic balance between bleeding and clotting) is observed in 25% to 36% of trauma patients and significantly increases mortality. Trauma-related coagulopathy typically involves dysfunction or depletion of coagulation factors, platelets, fibrinogen, and fibrinolysis. Each of these defects requires specific treatment to correct, while improper treatment consumes time, money, and limited resources, and worsens outcomes. Proper trauma treatment requires the rapid assessment of hemostatic state. The ideal test is performed at the point of care, is robust to environmental vibration, takes only a few minutes to perform, specifies the exact hemostatic defect(s), is easy to use, and presents easy to interpret results. Unfortunately, no commercially available test or combination of tests meets these criteria. Under this proposal HemoSonics will test the applicability of its proprietary Sonorheometry technology to assess coagulopathy at the point of care. We will assess potential technical barriers and validate our approach to this critical health care problem. Success in Phase I will pave the way to a Phase II award and product commercialization.