Bleeding is a complex medical problem. In patients who bleed 1 we first think of Clotting factor deficiencies and Hemophilia. However, bleeding is also dependent on blood flow, the vascular system, fibrinolysis, and platelets. The usual laboratory screening tests are prothrombin time, partial thromboplastin time, and platelet count. Another frequently used test is the skin incision, template bleeding time. There is recent dispute over the utility of this test. It has significant diagnostic potential, but is underutilized due to archaic design and variability. Through our own innovation, we automated the bleeding time test for the laboratory. The automated bleeding time measures platelet function and the earliest stage of clot formation. It can potentially screen patients for several congenital and acquired bleeding disorders, and has the potential to monitor therapy such as platelet transfusions, ticlid, ReoPro etc. The goal with this proposal is to establish diagnostic efficacy of the test through reliability and validity testing. An initial cross-section of 400 healthy individuals will be tested to establish stable measure of central tendency. We will determine external validity by sea and specificity testing. A cohort of patients with known diseases for prolonged bleeding time, and a normal cohort will be tested for false positive and negative results. The automated test is compared to the current template in-vivo test throughout the study. Future studies 'will address the predictive value for surgical and thrombocytopenic bleeding. This proposal is seeking funding to collect data for FDA marketing approval and we are a small business. This is a proposal that will be successful for the SBIR program. Our market analysis reveals a need for this test-one that measures vessel wall and blood interaction. PROPOSED COMMERCIAL APPLICATIONS Two million template bleeding time tests are done yearly. The template test is under utilized due to archaic design and unproven predictive value. A manufactured, simple, safe, automated and efficacious test with predictive value will encourage physicians to utilize this important test cost effectively.
Thesaurus Terms:biomedical automation, blood disorder diagnosis, diagnosis design /evaluation, diagnostic test, platelet, prothrombin time blood coagulation disorder, blood vessel, cytodiagnosis, diagnosis procedure safety, diagnosis quality /standard, method development clinical research, human subject, phlebotomyNational Heart, Lung and Blood Institute (NHLBI)
