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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

基本信息

批准号：
7909887
负责人：
FRANCESCO VIOLA
金额：
$ 29.86万
依托单位：
HEMOSONICS
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-08-06 至 2011-08-05
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7909887
关键词：
Address Anti-Inflammatory Agents Anti-inflammatory Antifibrinolytic Agents Aspirin Biomedical Engineering Blood Blood Banks Blood Clot Blood Platelets Blood coagulation Bypass Clinical Clinical Research Coagulation Process Cost Savings Cytolysis Data Defect Development Diagnostic tests Disabled Persons Dose Evaluation Event Exhibits Fibrinogen Fresh Frozen Plasmas Functional disorder Goals Healthcare Heme Hemorrhage Hemostatic Agents Hemostatic function Hospitals In Vitro Infection Kidney Failure Laboratories Lead Lung Measurement Measures Methods Myocardial Infarction Normal Range Operative Surgical Procedures Outcome Patient Care Patients Performance Pharmaceutical Preparations Phase Pilot Projects Plasma Platelet Count measurement Plavix Postoperative Period Procedures Process Proteins Published Comment Reaction Reference Values Reproducibility Research Risk Sampling Savings Selection for Treatments Small Business Innovation Research Grant Solutions Stroke Structural Protein Technology Testing Time Transfusion Ultrasonography Universities Variant Virginia Work base blood product clinical practice clopidogrel cost experience healthy volunteer improved innovation instrument medical schools mortality novel point of care point-of-care diagnostics prototype public health relevance research study response

项目摘要

DESCRIPTION (provided by applicant): Over 60% of the 600,000 patients undergoing cardio-pulmonary bypass (CPB) procedures in the US each year experience intra- and post-operative bleeding. Treatment options are available, each corresponding to a specific hemostatic defect: (a) fresh frozen plasma (FFP) to correct the plasma coagulation proteins, (b) platelet concentrate to restore platelets, (c) cryoprecipitate to restore fibrinogen, and (d) antifibrinolytics to slow the activity of the clot-dissolving proteins. However, clinical evidence strongly indicates that targeted use of these products can reduce mortality by 2.5X, myocardial infarction by 3X, renal failure by 13X, and stroke events by 3.6X, while producing 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 immunological reactions, infections, and unnecessary expenses. Proposed Solution: HemoSonics LLC is developing a POC instrument, the HemoSonics Global Hemostasis Analyzer (HS-GHA) that can directly quantify the function of the four hemostatic components, enabling appropriate selection of treatment. The HS-GHA is based on sonorheometry (SR), a novel ultrasound-based technology able to assess not only time to clot (dependent upon the plasma coagulation proteins) but also clot formation rate (dependent upon fibrinogen), clot stiffness (dependent upon fibrinogen and platelets), and time to lysis (dependent upon clot-dissolving proteins). If proven successful, the HS-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 (iv) improve patient's care. Feasibility of this approach will be established if it is demonstrated that SR can measure the function of the 4 components of hemostasis. This research is a collaborative effort between HemoSonics, LLC and the University of Virginia Department of Biomedical Engineering and School of Medicine. PUBLIC HEALTH RELEVANCE: Clinical evidence strongly indicates that improved management of bleeding with targeted use of blood products can reduce one-year mortality by 2.5X, myocardial infarction by 3X, renal failure by 13X, and stroke events by 3.6X, while producing cost savings of up to $4M/year per hospital. Unfortunately, management of bleeding remains suboptimal due to the limitations of current diagnostic tests. The goal of this proposal is to develop a novel point-of-care (POC) diagnostic instrument that will improve the current management of bleeding and usage of blood products, thus improving patients' outcomes and generating substantial cost savings.

描述（由申请人提供）：每年在美国接受心肺转流（CPB）手术的600，000例患者中，超过60%的患者发生术中和术后出血。治疗方案是可用的，每种治疗方案对应于特定的止血缺陷：（a）新鲜冷冻血浆（FFP），以纠正血浆凝固蛋白，（B）血小板浓缩物，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，临床证据强烈表明，有针对性地使用这些产品可以将死亡率降低2.5倍，心肌梗死降低3倍，肾衰竭降低13倍，中风事件降低3.6倍，同时每家医院每年节省高达400万美元。不幸的是，在护理点（POC）没有全球性的止血测试，这能够提供关于最佳治疗选择的快速结果。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，导致免疫反应，感染和不必要的费用的风险增加。建议的解决方案：HemoSonics LLC正在开发一种POC仪器，即HemoSonics全球止血分析仪（HS-GHA），可直接量化四种止血成分的功能，从而能够选择适当的治疗。HS-GHA基于声流变学（SR），这是一种新型超声技术，不仅能够评估凝血时间（取决于血浆凝固蛋白），还能够评估凝块形成速率（取决于纤维蛋白原）、凝块硬度（取决于纤维蛋白原和血小板）和溶解时间（取决于凝块溶解蛋白）。如果证明成功，HS-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）血库节省血液制品，以及（iv）改善患者护理。如果证明SR可以测量4种止血成分的功能，则将确定该方法的可行性。这项研究是HemoSonics，LLC和弗吉尼亚大学生物医学工程系和医学院的合作成果。公共卫生相关性：临床证据有力地表明，通过有针对性地使用血液制品来改善出血管理可以将一年死亡率降低2.5倍，心肌梗死降低3倍，肾衰竭降低13倍，中风事件降低3.6倍，同时每家医院每年节省高达400万美元的成本。不幸的是，由于目前诊断测试的局限性，出血的管理仍然不理想。该提案的目标是开发一种新型的床旁（POC）诊断仪器，该仪器将改善目前的出血管理和血液制品的使用，从而改善患者的结局并节省大量成本。