Development of a POC device to guide efficient use of blood products

 描述(由申请人提供)：问题：血液不能正常凝结是可预防的发病率、死亡率和不必要费用的主要来源。例如，在美国每年接受体外循环(CPB)手术的60万名患者中，超过60%的患者经历了过度出血，这需要输血产品。有四种治疗方案可供选择，每一种都对应于一种特定的止血缺陷：(A)新鲜冰冻血浆(FFP)以纠正血浆凝血因子；(B)浓缩血小板以恢复血小板；(C)冷沉淀以恢复纤维蛋白原；以及(D)抗纤溶药物以减缓凝块溶解蛋白的活性。然而，临床文献强烈表明，发病率和死亡风险，以及术后住院时间，在 一种剂量依赖的方式，增加了血液制品的使用。与此同时，有针对性地使用这些产品可以为每家医院每年节省高达400万美元。类似的推理可以推广到任何有大出血风险的外科手术，以及平民/军事创伤护理。不幸的是，在护理点(POC)没有可用的全球止血测试，它能够提供关于最佳治疗方案的快速结果。POC提供的测试无法提供所需信息，即使组合使用也是如此。因此，目前的临床实践是反复输血和主观评估出血。这一过程缓慢，而且容易过度输血，导致结果恶化和不必要费用的风险增加。HemoSonics的解决方案：HemoSonics LLC正在开发一种新型的PoC平台设备--全球止血分析仪(GHA)，以诊断和指导各种临床环境下的过度出血和过度凝血的治疗。GHA基于一项专利技术，能够表征止血的关键成分，即凝血因子、纤维蛋白原、血小板和纤溶。我们相信GHA将帮助：(I)外科团队实施正确的治疗，(Ii)医院通过减少不必要的输血来节省成本，(Iii)血库保存有价值的血液产品，最重要的是，(Iv)改善患者护理。拟议的SBIR工作：在该SBIR计划和其他资金来源(包括天使投资者)的支持下，我们已经证明了该技术的可行性，开发并测试了GHA的完全集成的原型。在第二阶段，我们打算在质量控制环境下完成制造设计，完成验证和确认，并提交美国和欧洲监管批准所需的所有必要文件。这项研究是HemoSonics、弗吉尼亚大学生物医学工程系和医学院以及Key Tech Inc.(马里兰州巴尔的摩)的合作成果。

 DESCRIPTION (provided by applicant): The Problem: The inability of blood to coagulate properly represents a major source of preventable morbidity, mortality, and unnecessary costs. For example, 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 stongly indicates that morbidity and mortality risks, as well as post-operative length of stay, increase in a dose-dependent way with increased use of blood products. Meanwhile, targeted use of these products can produce savings of up to $4m/year per hospital. Similar reasoning can be extended to any surgical procedure at high risk for major bleeding as well as civilian/military trauma care. 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' Solution: HemoSonics LLC is developing a novel POC platform device, the Global Hemostasis Analyzer (GHA), to diagnose and guide the treatment of excessive bleeding and overactive clotting in a variety of clinical settings. The GHA is based on a patented technology able to characterize the key components of hemostasis for which a treatment is readily available: coagulation factors, fibrinogen, platelets, and fibrinolysis. We believe 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 valuable blood products, and, most importantly, (iv) improve patient care. Proposed SBIR Work: With support from this SBIR program and other sources of funds (including angel investors), we have proven the feasibility of the technology, developed and tested a fully integrated prototype of the GHA. In Phase IIB, we intend to complete design for manufacturing under a quality control environment, complete verification and validation, and submit all the necessary documents required for US and European regulatory approval. This research is a collaborative effort between HemoSonics, the University of Virginia Department of Biomedical Engineering and School of Medicine, and Key Tech Inc (Baltimore, MD).