The monitoring and management of the hemostatic balance in neonatal and pediatric patients remains challenging. Although several conditions/procedures are known to have great impact in altering hemostatic function in this population, the differences between "childhood" and "adulthood" hemostasis make it challenging to determine and monitor the appropriate treatment(s). Furthermore, the systems that are available are mostly tailored for use in adult patients (they require large sample volumes for testing). Cardiac surgery for children with congenital heart defects represents an important indication where hemostatic monitoring is essential to determine the need for transfusion or anticoagulation. Congenital heart disease occurs in 0.8% of live births and the prevalence of transfusion during these procedures remains as high as 80%. However, several studies have shown that the liberal use of transfusions is associated with increased mortality, morbidity, infection and longer duration of mechanical ventilation/hospital stays in the ICU. In trauma, a retrospective study of 803 pediatric trauma patients showed that early coagulopathy was present in 37.9% of the patients and that it was greatly associated with mortality (13.4%) based on injury severity, increasing as high as 4X for patients with traumatic head injuries. Children with cancer comprise 8 to 22% of the pediatric patients with thrombosis. Aside from changes in the coagulation cascade due to the presence of the cancer, the incidence of venous thromboembolism associated with cancer therapy administration through central venous lines remains one of the biggest risk factor for thrombosis in children (60% of all pediatric blood clots and up to 90% in neonates). While there is a great need to monitor hemostasis in these patients, no true point-of-care (POC) device exists that can deliver global coagulation results quickly using a minimal amount of blood. HemoSonics'Proposed Solution: HemoSonics is developing a novel POC diagnostic instrument, the Global Hemostasis Analyzer (GHA), which has the capability of measuring the hemostatic profile from a sample of whole blood. The GHA is based on sonorheometry (SR), a patented technology able to assess the function of the coagulation factors, fibrinogen, platelets, and fibrinolysis. These outputs are tied to available treatments. Stand-alone prototypes have been designed that demonstrate the functionality of the technology. Proposed SBIR work: This Phase I proposal will determine the technical feasibility of a test chamber that utilizes sample volumes of 50ul (hence amenable for pediatric and neonate patients) and the viability of utilizing lyophilized reagents. In Phase II we will buil a compact prototype of our microfluidic chip and evaluate its performance in cardiac surgery, in order to test the hypothesis that SR can be implemented in a portable, easy to use, easy to interpret instrument suitable for use with these patients and that the information provided will ai in minimizing unnecessary transfusions, reducing overall healthcare spending and improving patients outcomes.

Public Health Relevance

The clinical literature clearly indicates that there is a need to monitor hemostatic function in pediatric and neonate patients. Rapid detection and correction of coagulation defects in these patients could significant improve care in many hospital settings ranging from cardiac surgery to trauma care. However, no true point-of- care (POC) device exists that can deliver global coagulation results using a minimal amount of blood from these patients as most available systems are tailored for adult patients. With this proposal we intend to address that need and thus overcome the limitations of current methods. This device will help provide better treatment for these patients and create significant economic savings in the practice of healthcare.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZHL1-CSR-C (S2))
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Warren, Ronald Q
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United States
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