The Problem: The inability of blood to coagulate properly represents a major source of preventable morbidity, mortality, and unnecessary costs. For example, over 60% of the 600,000 patients undergoing cardio- pulmonary bypass (CPB) procedures in the US each year experience excessive bleeding, which requires transfusions of blood products. There are four treatment options available, each corresponding to a specific hemostatic defect: (a) fresh frozen plasma (FFP) to correct the plasma coagulation factors, (b) platelet concentrate to restore platelets, (c) cryoprecipitate to restore fibrinogen, and (d) anti-fibrinolytics to slow the activity of the clot-dissolving proteins. However, clinical literature stongly indicates that morbidity and mortality risks, as well as post-operative length of stay, increase in a dose-dependent way with increased use of blood products. Meanwhile, targeted use of these products can produce savings of up to $4m/year per hospital. Similar reasoning can be extended to any surgical procedure at high risk for major bleeding as well as civilian/military trauma care. Unfortunately, there is no global test of hemostasis available at the point of care (POC), which is able to provide rapid results about the best treatment option. The tests that are available at POC can't provide the required information, even if used in combination. Thus, current clinical practice is iterative transfusion of blood products and subjective evaluation of bleeding. This process is slow and prone to over transfusions, resulting in increased risk of worsened outcomes and unnecessary expenses. HemoSonics' Solution: HemoSonics LLC is developing a novel POC platform device, the Global Hemostasis Analyzer (GHA), to diagnose and guide the treatment of excessive bleeding and overactive clotting in a variety of clinical settings. The GHA is based on a patented technology able to characterize the key components of hemostasis for which a treatment is readily available: coagulation factors, fibrinogen, platelets, and fibrinolysis. We believe the GHA will help: (i) the surgical team administer the correct treatment, (ii) the hospital save costs by reducing unnecessary transfusions, (iii) the blood bank save valuable blood products, and, most importantly, (iv) improve patient care. Proposed SBIR Work: With support from this SBIR program and other sources of funds (including angel investors), we have proven the feasibility of the technology, developed and tested a fully integrated prototype of the GHA. In Phase IIB, we intend to complete design for manufacturing under a quality control environment, complete verification and validation, and submit all the necessary documents required for US and European regulatory approval. This research is a collaborative effort between HemoSonics, the University of Virginia Department of Biomedical Engineering and School of Medicine, and Key Tech Inc (Baltimore, MD).

Public Health Relevance

Clinical evidence strongly indicates that improved management of bleeding with targeted use of blood products can reduce morbidity and mortality risks while producing significant cost savings. It has been estimated that each unit of blood products transfused increases the post-operative odds of severe infection by 76%, cardiac morbidity by 55%, neurological morbidity by 39%, and overall in-hospital mortality by 77%. Post-operative length of stay also increases by 0.82 days per unit transfused. Meanwhile, targeted use of these products can produce savings of up to $4m/year per hospital. Unfortunately, management of bleeding remains suboptimal due to the limitations of current diagnostic tests. The goal of this proposal is to complete the development a novel point-of-care (POC) diagnostic instrument that will improve the current management of bleeding and usage of blood products, thus improving patients' outcomes and generating substantial cost savings.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
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Special Emphasis Panel (ZHL1 (F1))
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Mitchell, Phyllis
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Ferrante, Elisa A; Blasier, Kiev R; Givens, Thomas B et al. (2016) A Novel Device for the Evaluation of Hemostatic Function in Critical Care Settings. Anesth Analg 123:1372-1379
Corey, F Scott; Walker, William F (2016) Sonic Estimation of Elasticity via Resonance: A New Method of Assessing Hemostasis. Ann Biomed Eng 44:1405-24