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

SBIR 第一阶段：一种创新的护理点设备，可以快速检测和诊断创伤引起的凝血病

• 批准号: 1346109
• 负责人: Ari Karchin
• 金额: $ 15万
• 依托单位: Stasys Medical Corp
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-01-01 至 2014-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1346109&HistoricalAwards=false
• 关键词: SBIR; Phase; innovative; point; care

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.

这项小企业创新研究（SBIR）一期项目将促进一种即时护理设备的技术开发，以测量凝血过程中全血中血小板的力量。全世界每年有近500万人死于创伤，美国每小时有17人死于创伤性凝血病（TIC）导致的大量失血，这是一种由严重损伤引起的全身止血（凝血）障碍。目前的SBIR I期合同将资助一项可行性研究，研究通过磁性传感器测量凝血过程中血小板力的能力。这个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II期项目成为可能，该项目将展示该技术在个性化基础上检测创伤患者凝血功能障碍的能力，以及抗血小板和/或抗凝药物患者的能力。这个项目更广泛的影响/商业潜力将是减少往往是年轻的、有生产力的社会成员可预防的死亡。创伤是年轻人（1-45岁年龄组）最重要的死亡原因，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增加的主要原因。凝血功能障碍常使出血加重，这是病人的无能。使血液凝固，并适当地密封出血的伤口。目前，急性创伤性凝血功能障碍（TIC）发生在1 / 4的严重创伤病例中，但难以发现和治疗。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导方针，对患者使用哪种输血产品或药物进行半盲决定，以便止血，并且必须根据他们的决定采取行动。黄金小时吗?（即受伤后大约60分钟）最有可能挽救生命、降低发病率和降低医院费用。