SBIR Phase I: An innovative point-of-care device that can rapidly detect and diagnose trauma-induced coagulopathy

这个小型企业创新研究(SBIR)第一阶段项目将促进护理点设备的技术开发，以测量全血在凝血过程中的血小板作用力。全球每年有近500万人死于创伤，美国每小时有17人死于创伤。这些死亡是由于创伤引发的凝血障碍(TIC)导致的大量失血所致，TIC是严重创伤引起的止血(凝血)的系统性损害。目前的SBIR第一阶段奖将资助一项可行性研究，即通过基于磁性的传感器测量凝血过程中的血小板作用力的能力。这项SBIR第一阶段提案的具体技术目标是改进我们的磁基传感器的信号检测。这些目标的成功完成将使第二阶段项目得以实现，该项目将展示这项技术在个性化基础上检测创伤患者以及接受抗血小板和/或抗凝血药物治疗的患者的凝血功能障碍的能力。这个项目的更广泛的影响/商业潜力将是减少社会中往往是年轻的、有生产力的成员可预防的死亡。创伤是年轻人(1-45岁年龄组)最主要的死亡原因，每年花费1350亿美元的医疗保健费用。创伤患者出血过多是导致死亡和医疗费用的主要原因。大量出血往往会因凝血障碍而恶化，这就是患者的能力？S的血液无法凝结和适当地封闭出血的伤口。目前，每4例严重创伤中就有1例发生急性创伤性凝血障碍(TIC)，但发现和治疗难度较大。因此，急诊科医生必须根据他们的培训、过去的经验和模糊的临床指南，半盲目地决定给病人使用哪些输液产品或药物来止血，并必须在黄金时段内根据他们的决定采取行动。(即受伤后大约60分钟)，以最大可能挽救生命、减少发病率和降低医院费用。

This Small Business Innovation Research (SBIR) Phase I project will facilitate technological development of a point-of-care device to measure the forces of platelets from whole blood during clotting. Trauma accounts for nearly 5 million deaths per year worldwide and 17 deaths per hour in the U.S. These deaths arise from an extensive loss of blood due to trauma-induced coagulopathy (TIC), which is a systemic impairment of hemostasis (blood clotting) caused by severe injury. The current SBIR Phase I award will fund a feasibility study on the ability to measure platelet forces during coagulation by a magnetic-based sensor. The specific technical goal of this SBIR Phase I proposal is to improve the signal detection of our magnetic-based sensor. Successful completion of these objectives will enable a Phase II project that will demonstrate the ability of this technology to detect clotting dysfunction in trauma patients on a personalized basis, as well as patients on anti-platelet and or anti-coagulation medications. The broader impact/commercial potential of this project will be to reduce preventable deaths of often young, productive members of society. Trauma is the most imporatn cause of death among young people (age group 1-45 years) and costs $135B in healthcare dollars annually. Excessive bleeding in a trauma patient is a major reason for deaths and medical costs. Excessive bleeding is often made worse by coagulopathy, which is the inability of a patient?s blood to coagulate and properly seal bleeding wounds. Currently, acute trauma-induced coagulopathy (TIC) occurs in 1 in 4 severe trauma cases, but is hard to detect and treat. As a consequence, an emergency department physician must make a semi-blind decision on which transfusion products or drugs to administer to a patient in order to stop the bleeding based upon their training, past experience, and vague clinical guidelines and must act upon their decision within the ?golden hour? (i.e. roughly 60 minutes after injury) to have the best likelihood to save lives, reduce morbidity, and reduce hospital costs.