Development of a point of care diagnostic to guide efficient usage of blood produ

开发护理点诊断以指导血液制品的有效使用

• 批准号: 8591277
• 负责人: FRANCESCO VIOLA
• 金额: $ 105.43万
• 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 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8591277
• 关键词: Area Under Curve; Biomedical Engineering; Blood; Blood Banks; Blood Coagulation Factor; Blood Platelets; Bypass; Cardiac; Clinical; Clinical Research; Coagulation Process; Cost Savings; Cytolysis; Data; Defect; Development; Devices; Diagnostic tests; Dose; Drainage procedure; Evaluation; Fibrinogen; Fibrinolysis; Fresh Frozen Plasmas; Goals; Healthcare; Hematocrit procedure; Hemorrhage; Hemostatic Agents; Hemostatic function; Hospital Mortality; Hospitals; Hour; Human Resources; Infection; Length of Stay; Literature; Lung; Measurement; Measures; Morbidity - disease rate; Neurologic; Operative Surgical Procedures; Outcome; Output; Patient Care; Patients; Performance; Phase; Plasma; Postoperative Period; Preparation; Procedures; Process; Proteins; Reagent; Reference Values; Reproducibility; Research; Risk; Savings; Selection for Treatments; Site; Small Business Innovation Research Grant; Solutions; Specificity; Test Result; Testing; Time; Training; Transfusion; Tube; Universities; Virginia; Work; base; blood product; clinical practice; cost; experience; improved; instrument; medical schools; mortality; new technology; novel; point of care; point-of-care diagnostics; prospective; prototype; public health relevance; research clinical testing; time interval

DESCRIPTION (provided by applicant): The Problem: 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 strongly indicates that morbidity and mortality risks increase in a dose-dependent way with increased use of blood products. It has been estimated that each unit transfused increases the post-operative odds of severe infection by 76%, cardiac morbidity by 55%, neurological morbidity by 39%, and overall in- hospital mortality by 77%. Furthermore post-operative length of stay increases by 0.82 days per unit transfused. Meanwhile, targeted use of these products can produce savings of up to $4M/year per hospital. 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' Proposed Solution: HemoSonics LLC is developing a POC instrument, the Global Hemostasis Analyzer (GHA) that can quantify the function of the four hemostatic components, enabling correct selection of treatment. The GHA is based on sonorheometry (SR), a novel technology able to assess not only time to clot (dependent upon the plasma coagulation factors) but also clot formation rate (dependent upon fibrinogen), clot stiffness (dependent upon fibrinogen and platelets), and time to lysis (dependent upon clot-dissolving proteins). 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 blood products, and, most importantly, (iv) improve patient care. Proposed SBIR Work: In Phase I, we successfully completed demonstration of the feasibility of SR to measure the function of the four hemostatic components. In Phase II, we intend to finalize prototype development and evaluate its performance in CPB, in order to test the hypothesis that SR can provide information that will aid in minimizing unnecessary transfusions, reducing overall healthcare spending and improving patient outcomes. Furthermore, data obtained in these studies will be utilized for FDA regulatory approval. This research is a collaborative effort between HemoSonics, the University of Virginia Department of Biomedical Engineering and School of Medicine, and Medical College of Virginia (Virginia Commonwealth University).

描述（由申请人提供）：问题：每年在美国接受心肺转流（CPB）手术的600，000例患者中，超过60%的患者会出现过度出血，这需要输注血液制品。有四种治疗方案可供选择，每种治疗方案对应于特定的止血缺陷：（a）新鲜冷冻血浆（FFP），以纠正血浆凝血因子，（B）血小板浓缩液，以恢复血小板，（c） 冷沉淀以恢复纤维蛋白原，和（d）抗纤维蛋白溶解剂以减缓凝块溶解蛋白的活性。然而，临床文献强烈表明，随着血液制品使用的增加，发病率和死亡率风险以剂量依赖性方式增加。据估计，每输一个单位的血会使术后严重感染的几率增加76%，心脏病发病率增加55%，神经系统发病率增加39%，总的住院死亡率增加77%。此外，术后住院时间增加了0.82天每单位输血。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。不幸的是，在护理点（POC）没有全球止血测试， 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的信息，即使组合使用。因此，目前的临床实践是血液制品的反复输注和出血的主观评价。这个过程是缓慢的，容易过度输血，导致恶化的结果和不必要的费用的风险增加。HemoSonics提出的解决方案：HemoSonics LLC正在开发一种POC仪器，即全球止血分析仪（GHA），可以量化四种止血成分的功能，从而能够正确选择治疗。GHA基于声流变学（SR），这是一种新型技术，不仅能够评估凝块时间（取决于血浆凝血因子），还能够评估凝块形成率（取决于纤维蛋白原）、凝块硬度（取决于纤维蛋白原和血小板）和时间溶解（取决于凝块溶解蛋白）。全球人道主义协会将帮助：（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） 血库保存血液制品，最重要的是，（iv）改善病人护理。拟议的SBIR工作：在第一阶段，我们成功完成了SR测量四种止血成分功能的可行性证明。在第二阶段，我们打算完成原型开发并评估其在CPB中的性能，以测试SR可以提供有助于减少不必要的输血、减少整体医疗支出和改善患者结局的信息的假设。此外，这些研究中获得的数据将用于FDA监管批准。这项研究是一项合作努力 HemoSonics、弗吉尼亚大学生物医学工程系和医学院以及弗吉尼亚医学院（弗吉尼亚联邦大学）之间的合作。