Over 60% of the 600,000 patients undergoing cardio-pulmonary bypass (CPB) procedures in the US each year experience intra- and post-operative bleeding. Treatment options are available, each corresponding to a specific hemostatic defect: (a) fresh frozen plasma (FFP) to correct the plasma coagulation proteins, (b) platelet concentrate to restore platelets, (c) cryoprecipitate to restore fibrinogen, and (d) antifibrinolytics to slow the activity of the clot-dissolving proteins. However, clinical evidence strongly indicates that targeted use of these products can reduce mortality by 2.5X, myocardial infarction by 3X, renal failure by 13X, and stroke events by 3.6X, while producing savings of up to $4M/year per hospital. 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 immunological reactions, infections, and unnecessary expenses. Proposed Solution: HemoSonics LLC is developing a POC instrument, the HemoSonics Global Hemostasis Analyzer (HS-GHA) that can directly quantify the function of the four hemostatic components, enabling appropriate selection of treatment. The HS-GHA is based on sonorheometry (SR), a novel ultrasound-based technology able to assess not only time to clot (dependent upon the plasma coagulation proteins) but also clot formation rate (dependent upon fibrinogen), clot stiffness (dependent upon fibrinogen and platelets), and time to lysis (dependent upon clot-dissolving proteins). If proven successful, the HS-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 blood products, and (iv) improve patient's care. Feasibility of this approach will be established if it is demonstrated that SR can measure the function of the 4 components of hemostasis. This research is a collaborative effort between HemoSonics, LLC and the University of Virginia Department of Biomedical Engineering and School of Medicine.

Public Health Relevance

Clinical evidence strongly indicates that improved management of bleeding with targeted use of blood products can reduce one-year mortality by 2.5X, myocardial infarction by 3X, renal failure by 13X, and stroke events by 3.6X, while producing cost 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 develop 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 I (R43)
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Special Emphasis Panel (ZRG1-VH-E (10))
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Mitchell, Phyllis
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United States
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Groves, Danja S; Winegar, Deborah A; Fernandez, Lucas G et al. (2018) Comparison of Coagulation Parameters in Arterial and Venous Blood in Cardiac Surgery Measured Using the Quantra System. J Cardiothorac Vasc Anesth :
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