The Problem: 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 strongly indicates that morbidity and mortality risks increase in a dose-dependent way with increased use of blood products. It has been estimated that each unit 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%. Furthermore post-operative length of stay 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, 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'Proposed Solution: HemoSonics LLC is developing a POC instrument, the Global Hemostasis Analyzer (GHA) that can quantify the function of the four hemostatic components, enabling correct selection of treatment. The GHA is based on sonorheometry (SR), a novel technology able to assess not only time to clot (dependent upon the plasma coagulation factors) but also clot formation rate (dependent upon fibrinogen), clot stiffness (dependent upon fibrinogen and platelets), and time to lysis (dependent upon clot-dissolving proteins). 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 blood products, and, most importantly, (iv) improve patient care. Proposed SBIR Work: In Phase I, we successfully completed demonstration of the feasibility of SR to measure the function of the four hemostatic components. In Phase II, we intend to finalize prototype development and evaluate its performance in CPB, in order to test the hypothesis that SR can provide information that will aid in minimizing unnecessary transfusions, reducing overall healthcare spending and improving patient outcomes. Furthermore, data obtained in these studies will be utilized for FDA regulatory approval. This research is a collaborative effort between HemoSonics, the University of Virginia Department of Biomedical Engineering and School of Medicine, and Medical College of Virginia (Virginia Commonwealth University).

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 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.

Agency
National Institute of Health (NIH)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44HL103030-03
Application #
8720050
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Mitchell, Phyllis
Project Start
Project End
Budget Start
Budget End
Support Year
3
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Hemosonics
Department
Type
DUNS #
City
Charlottesville
State
VA
Country
United States
Zip Code
22903