A diagnostic instrument to manage hemostasis in chronic liver disease

一种用于治疗慢性肝病止血的诊断仪器

基本信息

批准号：
8324671
负责人：
FRANCESCO VIOLA
金额：
$ 63.19万
依托单位：
HEMOSONICS
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-01 至 2014-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8324671
关键词：
Accident and Emergency department Admission activity Adverse reactions Affect Allergic Reaction Alteplase Bacterial Infections Bilirubin Biomedical Engineering Blinded Blood Banks Blood Coagulation Factor Blood Platelets Blood coagulation Blood specimen Cirrhosis Clinic Clinical Clinical Management Clinical Research Coagulation Process Cost Savings Cytolysis Data Defect Diagnostic Diagnostic tests Disease Dose Enrollment Equilibrium Evidence based intervention Fibrin Fibrinogen Fibrinolysis Fresh Frozen Plasmas Functional disorder Generations Goals Healthcare Hematocrit procedure Hemolysis Hemorrhage Hemostatic Agents Hemostatic function Hepatology Hospitals Housing Human Resources In Vitro Infection Inpatients Intensive Care Units International Intervention Investigation Laboratories Lead Lipids Liver Failure Liver diseases Measurement Measures Mechanics Morbidity - disease rate Normal Range Outcome Outcome Study Patient Care Patients Performance Perioperative Phase Physicians Plasma Platelet Count measurement Procedures Process Prophylactic treatment Proteins Renal function Reporting Reproducibility Research Resources Risk Sampling Seminal Services Small Business Innovation Research Grant Solutions Source Technology Testing Thrombocytopenia Time Training Transfusion Transplant Surgeon Transplantation Ultrasonography Universities Variant Virginia Virus Diseases Whole Blood Work adverse outcome base blood product chronic liver disease clinical efficacy clinical practice cost design experience graphical user interface healthy volunteer high risk improved instrument liver biopsy liver transplantation medical schools mortality novel novel diagnostics patient population prospective prototype public health relevance research clinical testing research study response standard of care symposium time use tool

项目摘要

DESCRIPTION (provided by applicant): The clinical evaluation and management of hemostasis in the 5 million patients affected by chronic liver diseases (CLD) is poorly understood. Data presented at two International Symposia on Coagulation in Liver Disease and summarized in a recent edition of Clinics in Liver Disease strongly support the presence of an unmet clinical need for investigation in this field. Improved investigation of hemostasis is needed to assess bleeding risks and guide clinical decisions. Few examples are listed in the table below, showing how clinical practice could be improved for CLD patients. Clinical decision for invasive interventions such as liver biopsy Improved assessment of hemostasis => Don't perform procedure if hemostatic profile reveals high risk of bleeding Usage of blood products for prophylaxis or therapy purposes Improved assessment of hemostasis => Guide the selection and transfusion of blood products: (i) Fresh frozen plasma (FFP) and/or cryoprecipitate to replenish blood coagulation proteins. (ii) Platelet concentrates to replenish platelets level. (iii) Anti-fibrinolytics to slow down clot dissolution. Perioperative management of blood product transfusions such as in the case of liver transplant Improved assessment of hemostasis => Guide transfusion of blood products as above Clinical decisions in the emergency room and intensive care unit Improved assessment of hemostasis => Guide transfusion of blood products as above The management of blood products is particularly important for in CLD patients at risk or experiencing bleeding episodes. However, the use of blood products should be carefully optimized in order to save scarce resources, minimize the risks of allergic reactions, viral and bacterial infections, and reduce health-care spending. A recent report indicated that improved management of hemostasis in liver transplant alone could save over $370K/year (assuming an hospital performing 42 transplants/year) while reducing complications related to over transfusion of blood products by 2.6X. Unfortunately, there is no viable comprehensive test of hemostasis able to provide accurate management of CLD patients. While several studies have shown that current tests are unable to effectively quantify the hemostatic functions in CLD and do not correlate with bleeding outcomes, clinical decisions are being made daily using these unfounded criteria, leading to erroneous and potentially hazardous treatments. The need for alternatives has been apparent since seminal studies showing the fallacy of current tests in CLD. HemoSonics' Proposed Solution: HemoSonics LLC is developing an instrument, the HemoSonics' Global Hemostasis Analyzer or HS-GHA that can quantify hemostasis function to guide appropriate and evidence based interventions. 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 factors) but also clot formation rate (also dependent upon coagulation factors), clot stiffness (dependent upon fibrin assembly and platelet function), and time to lysis (dependent upon fibrinolytic proteins). If proven successful, the HS-GHA will help: (i) physicians provide 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's care. Proposed SBIR Work: In Phase I we intend to complete demonstration of the feasibility of SR as a diagnostic tool to quantify abnormalities of hemostasis that are common in CLD. In this Phase II we intend to demonstrate the clinical value and thus the commercial potential of our technology. We will design and assemble a stand- alone clinical prototype with disposable cartridges, and perform a small clinical study on cirrhotic patients. A positive conclusion from this study will demonstrate the ability of sonorheometry to recognize specific hemostatic defects that lead to excessive bleeding and the need to transfuse blood products. 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: The clinical evaluation and management of hemostasis in the 5 million patients affected by chronic liver diseases (CLD) is poorly understood. While improved management of hemostasis can resolve in improved patients care and substantial cost savings, this task currently remains suboptimal due to the many limitations of available diagnostic tests. The goal of this SBIR proposal is to develop and test the clinical efficacy of a novel diagnostic instrument that will improve the current management of hemostasis in CLD patients, thus improving patients' outcomes and generating significant cost savings.

描述（由申请人提供）：对 500 万慢性肝病 (CLD) 患者的止血临床评估和管理知之甚少。两次国际肝病凝血研讨会上提出的数据以及最近一期《肝病临床》中总结的数据强烈支持这一领域的研究存在未满足的临床需求。需要改进止血研究来评估出血风险并指导临床决策。下表列出了几个例子，展示了如何改善慢性肺病患者的临床实践。肝活检等侵入性干预措施的临床决策改进止血评估 => 如果止血结果显示出血风险较高，则不要进行手术使用血液制品进行预防或治疗改进止血评估 => 指导血液的选择和输血产品： (i) 新鲜冰冻血浆 (FFP) 和/或冷沉淀，以补充凝血蛋白。 (ii) 浓缩血小板以补充血小板水平。 (iii) 抗纤溶药以减缓血块溶解。血液制品输注（例如肝移植）的围手术期管理改进止血评估 => 如上所述指导血液制品输注急诊室和重症监护病房的临床决策改进止血评估 => 如上所述指导血液制品输注血液制品的管理对于有风险或正在经历出血的 CLD 患者尤其重要。然而，应该仔细优化血液制品的使用，以节省稀缺资源，最大限度地减少过敏反应、病毒和细菌感染的风险，并减少医疗保健支出。最近的一份报告表明，仅改善肝移植的止血管理每年就可以节省超过 37 万美元（假设一家医院每年进行 42 例移植手术），同时将与过度输注血液制品相关的并发症减少 2.6 倍。不幸的是，没有可行的综合止血测试能够为慢性肺病患者提供准确的管理。虽然一些研究表明，当前的测试无法有效量化慢性肺病的止血功能，并且与出血结果不相关，但每天都使用这些毫无根据的标准做出临床决策，导致错误和潜在危险的治疗。自从开创性研究显示当前慢性肺病测试的谬误以来，对替代方案的需求就显而易见了。 HemoSonics 提出的解决方案：HemoSonics LLC 正在开发一种仪器，即 HemoSonics 的全局止血分析仪或 HS-GHA，它可以量化止血功能，以指导适当的、基于证据的干预措施。 HS-GHA 基于声测速法 (SR)，这是一种基于超声波的新型技术，不仅能够评估凝血时间（取决于血浆凝血因子），还能够评估凝块形成率（也取决于凝血因子）、凝块硬度（取决于纤维蛋白组装和血小板功能）和裂解时间（取决于纤溶蛋白）。如果证明成功，HS-GHA 将帮助：(i) 医生提供正确的治疗，(ii) 医院通过减少不必要的输血节省成本，(iii) 血库节省血液制品，最重要的是，(iv)改善患者护理。拟议的 SBIR 工作：在第一阶段，我们打算完成 SR 作为诊断工具的可行性论证，以量化 CLD 中常见的止血异常。在第二阶段，我们打算展示我们技术的临床价值以及商业潜力。我们将设计和组装带有一次性药筒的独立临床原型，并对肝硬化患者进行小型临床研究。这项研究的积极结论将证明声测速法能够识别导致过度出血和需要输注血液制品的特定止血缺陷。这项研究是 HemoSonics, LLC 与弗吉尼亚大学生物医学工程系和医学院之间的合作成果。公众健康相关性：对 500 万慢性肝病 (CLD) 患者的止血临床评估和管理知之甚少。虽然改进止血管理可以改善患者护理并节省大量成本，但由于现有诊断测试的许多限制，这项任务目前仍然不理想。该 SBIR 提案的目标是开发和测试一种新型诊断仪器的临床疗效，该仪器将改善 CLD 患者目前的止血管理，从而改善患者的治疗结果并显着节省成本。