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

开发POC装置以指导血液制品的有效使用

• 批准号: 9032513
• 负责人: FRANCESCO VIOLA
• 金额: $ 99.96万
• 依托单位: HEMOSONICS
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-06 至 2017-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9032513
• 关键词: Baltimore; Biomedical Engineering; Blood; Blood Banks; Blood Coagulation Factor; Blood Platelets; Bypass; Cardiac; Clinical; Clinical Research; Coagulation Process; Controlled Environment; Cost Savings; Data; Defect; Development; Devices; Diagnosis; Diagnostic tests; Dose; Europe; European; Evaluation; Fibrinogen; Fibrinolysis; Fresh Frozen Plasmas; Funding Agency; Goals; Hemorrhage; Hemostatic Agents; Hemostatic function; Hospital Mortality; Hospitals; Infection; Legal patent; Length of Stay; Literature; Lung; Military Personnel; Morbidity - disease rate; Neurologic; Operative Surgical Procedures; Outcome; Patient Care; Patient-Focused Outcomes; Patients; Performance; Phase; Plasma; Postoperative Period; Procedures; Process; Proteins; Quality Control; Research; Risk; Savings; Series; Small Business Innovation Research Grant; Source; System; Technology; Testing; Time; Transfusion; United States; Universities; Virginia; Work; base; blood product; clinical practice; cost; design; experience; high risk; improved; instrument; medical schools; mortality; novel; point of care; point-of-care diagnostics; programs; prototype; public health relevance; trauma care; verification and validation

 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).

 描述（由申请人提供）： 问题：血液无法正常凝固是可预防的发病率、死亡率和不必要费用的主要来源。例如，在 600,000 名接受体外循环 (CPB) 手术的患者中，超过 60% 的患者。在美国，每年都会出现过度出血，这需要输注血液制品。有四种治疗方案可供选择，每种方案都对应一种特定的止血缺陷：(a) 新鲜冰冻血浆 (FFP)。纠正血浆凝固因子，（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）抗纤维蛋白溶解剂以减缓血栓溶解蛋白的活性。死亡风险以及术后住院时间的增加 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，类似的推理可以扩展到任何大出血和高风险的外科手术。不幸的是，护理点 (POC) 没有可用的全球止血测试，该测试能够快速提供有关最佳治疗方案的结果。所需的信息，即使组合使用。因此，目前的临床实践是反复输注血液制品和对出血进行主观评估，这一过程缓慢且容易发生过度输血，从而导致结果恶化和不必要费用的风险增加。HemoSonics LLC 正在开发一种新型 POC 平台。设备，全球止血分析仪 (GHA)，用于在各种临床环境中诊断和指导治疗过度出血和过度凝血 GHA 基于能够表征关键组件的专利技术。易于使用的止血治疗：凝血因子、纤维蛋白原、血小板和纤维蛋白溶解 我们相信 GHA 将有助于：(i) 手术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) 血库保存宝贵的血液制品，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，我们已经证明了这一点。在IIB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）之间的合作成果。