The Problem: Venous thromboembolism (VTE), which encompasses the diseases of deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common and life-threatening problem amongst cancer patients. In population-based studies, cancer has been associated with a 4-fold increase risk for VTE;in cancer patients undergoing systemic chemotherapy treatment the risk increases to over 6-fold. Several risk factors have been identified, such as primary site of cancer, metastatic disease, surgery, age/race and presence of comorbid conditions. However, the individual risk factors lack predictive power to effectively identify high-risk patients and VTE remains the second leading cause of death in cancer patients. Better tools for the identification of patients at high-risk for VTE will have direct effects on patient mortality, morbidity, quality of life as well as length of hospitalization, cost of treatment and consumption of health care resources. Although several tests, such as plasma fibrinogen concentration, platelet counts and D-dimer have been used in clinical settings to detect hypercoagulability in cancer patients, these tests lack the predictive value necessary to identify risks and the need for prophylactic treatment. Hypercoagulability in cancer is caused by the activation of the clotting cascade, inhibition of fibrinolytic activity and platelet activation/aggregation. However, no existing global test of hemostasis is capable of providing rapid and accurate results for these parameters. HemoSonics'Proposed Solution: HemoSonics LLC is developing a point-of-care (POC) instrument, the Global Hemostasis Analyzer (GHA) based on a novel ultrasound-based technology, sonorheometry (SR), that generate output parameters that quantify the functional role of four hemostatic components: coagulation factors, fibrinogen, platelets, and fibrinolysis. We hypothesize that the GHA could help: (i) doctors identify cancer patients at high risk for the development of VTE, (ii) monitor thromboprophylactic treatment, (iii) improve patient care, quality of life and prognosis and (iv) reduce the use of health care resources. Proposed SBIR work: This Phase I proposal will determine the feasibility of using SR to identify cancer patients at high risk for VTE. In Phase II we will expand the studies to encompass a larger number of patients, some of which will not only be undergoing chemotherapy but also receiving thromboprophylactic treatment due to surgery. The goal will be to demonstrate the effectiveness of the GHA in monitoring the effects of anticoagulant therapies in the reduction to VTE incidence in cancer patients known to be at higher risk due to surgery. This research is a collaborative effort between HemoSonics and the University of Virginia, School of Medicine.

Public Health Relevance

Venous thromboembolism (VTE), a condition of excessive clotting, is a common and life-threatening problem amongst cancer patients. Patients with cancer are at a 4-fold increase risk for VTE, which increases further to 6-fold when they are undergoing systemic chemotherapy treatment. Despite several known risk factors and biomarkers, identifying high-risk patients remains a challenging problem and VTE continues to be the second leading cause of death in cancer patients. The goal of this proposal is to test the hypothesis that the HemoSonics'Global Hemostasis Analyzer (GHA) can identify patients at high-risk for VTE in a small cohort of cancer patients undergoing chemotherapy. Early detection can lead to treatment with oral anticoagulants to prevent excessive clotting, thus reducing patient mortality, morbidity, length of hospitalization, cost of treatment and consumption of health care resources.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-VH-F (10))
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Evans, Gregory
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