Assessment of Hypercoagulability in Cancer Patients Using Sonorheometry

使用声流变测量法评估癌症患者的高凝状态

• 批准号: 8779360
• 负责人: FRANCESCO VIOLA
• 金额: $ 20.29万
• 依托单位: HEMOSONICS
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-09 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8779360
• 关键词: Age; Anticoagulant therapy; Anticoagulants; Area Under Curve; Biological Assay; Biological Markers; Blood Coagulation Factor; Blood Platelets; Cancer Center; Cancer Patient; Cause of Death; Clinical; Coagulation Process; Confidence Intervals; Consumption; Control Groups; Data; Deep Vein Thrombosis; Detection; Development; Disease; Disseminated Malignant Neoplasm; Early Diagnosis; Effectiveness; Enrollment; Fibrin fragment D; Fibrinogen; Fibrinolysis; Generations; Goals; Healthcare; Hematology; Hemostatic Agents; Hemostatic function; Hospitalization; Human Resources; Incidence; Individual; Institutional Review Boards; Lead; Length; Life; Malignant Neoplasms; Malignant neoplasm of pancreas; Matched Group; Measurement; Measures; Monitor; Morbidity - disease rate; Multicenter Studies; Operative Surgical Procedures; Oral; Output; Patient Care; Patients; Performance; Phase; Physicians; Plasma; Platelet Activation; Platelet Count measurement; Population; Predictive Value; Prophylactic treatment; Pulmonary Embolism; Quality of life; Race; Receiver Operating Characteristics; Recruitment Activity; Research; Resources; Risk; Risk Factors; Role; Site; Small Business Innovation Research Grant; Solutions; Technology; Test Result; Testing; Thrombin; Thromboembolism; Thrombophilia; Treatment Cost; Ultrasonography; Universities; Venous; Virginia; Work; base; cancer site; chemotherapy; clinical practice; cohort; follow-up; high risk; improved; indexing; instrument; malignant stomach neoplasm; medical schools; mortality; novel; oncology; outcome forecast; point of care; population based; prevent; programs; prospective; public health relevance; time interval; tool

DESCRIPTION (provided by applicant): The Problem: Venous thromboembolism (VTE), which encompasses the diseases of deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common and life-threatening problem amongst cancer patients. In population-based studies, cancer has been associated with a 4-fold increase risk for VTE; in cancer patients undergoing systemic chemotherapy treatment the risk increases to over 6-fold. Several risk factors have been identified, such as primary site of cancer, metastatic disease, surgery, age/race and presence of comorbid conditions. However, the individual risk factors lack predictive power to effectively identify high-risk patients and VTE remains the second leading cause of death in cancer patients. Better tools for the identification of patients at high-risk for VTE will have direct effects on patient mortality, morbidity, quality of life as well as length of hospitalization, cost of treatment and consumption of health care resources. Although several tests, such as plasma fibrinogen concentration, platelet counts and D-dimer have been used in clinical settings to detect hypercoagulability in cancer patients, these tests lack the predictive value necessary to identify risks and the need for prophylactic treatment. Hypercoagulability in cancer is caused by the activation of the clotting cascade, inhibition of fibrinolytic activity and platelet activation/aggregation. However, no existing global test of hemostasis is capable of providing rapid and accurate results for these parameters. HemoSonics' Proposed Solution: HemoSonics LLC is developing a point-of-care (POC) instrument, the Global Hemostasis Analyzer (GHA) based on a novel ultrasound-based technology, sonorheometry (SR), that generate output parameters that quantify the functional role of four hemostatic components: coagulation factors, fibrinogen, platelets, and fibrinolysis. We hypothesize that the GHA could help: (i) doctors identify cancer patients at high risk for the development of VTE, (ii) monitor thromboprophylactic treatment, (iii) improve patient care, quality of life and prognosis and (iv) reduce the use of health care resources. Proposed SBIR work: This Phase I proposal will determine the feasibility of using SR to identify cancer patients at high risk for VTE. In Phase II we will expand the studies to encompass a larger number of patients, some of which will not only be undergoing chemotherapy but also receiving thromboprophylactic treatment due to surgery. The goal will be to demonstrate the effectiveness of the GHA in monitoring the effects of anticoagulant therapies in the reduction to VTE incidence in cancer patients known to be at higher risk due to surgery. This research is a collaborative effort between HemoSonics and the University of Virginia, School of Medicine.

问题：静脉血栓栓塞症(VTE)，包括深静脉血栓形成(DVT)和肺栓塞(PE)等疾病，是癌症患者中常见的威胁生命的问题。在基于人群的研究中，癌症与静脉血栓栓塞症的风险增加了4倍；在接受全身化疗的癌症患者中，风险增加到6倍以上。已经确定了几个危险因素，如癌症的原发部位、转移性疾病、手术、年龄/种族和是否存在合并疾病。然而，个体风险因素缺乏有效识别高危患者的预测能力，VTE仍然是癌症患者的第二大死亡原因。更好的工具来识别高危患者 VTE将直接影响患者的死亡率、发病率、生活质量以及住院时间、治疗成本和卫生保健资源的消耗。虽然一些检测方法，如血浆纤维蛋白原浓度、血小板计数和D-二聚体已用于临床，以检测癌症患者的高凝状态，但这些检测缺乏必要的预测价值，无法识别风险和预防性治疗的必要性。癌症的高凝状态是由于凝血级联反应的激活、纤溶活性的抑制和 血小板活化/聚集。然而，现有的全球止血试验不能为这些参数提供快速和准确的结果。HemoSonics建议的解决方案：HemoSonics LLC正在开发一种基于超声的新技术超声流变仪(SR)的护理点(POC)仪器--全球止血分析仪(GHA)，该仪器可以生成量化四种止血成分功能作用的输出参数：凝血因子、纤维蛋白原、血小板和纤溶。我们假设GHA可以帮助：(I)医生识别罹患VTE的高危癌症患者，(Ii)监测血栓预防治疗，(Iii)改善患者护理、生活质量和预后，以及(Iv)减少卫生保健资源的使用。建议的SBIR工作：这项第一阶段的建议将确定使用SR来识别VTE高危癌症患者的可行性。在第二阶段，我们将扩大研究范围，以涵盖更多的患者，其中一些患者不仅将接受化疗，还将接受手术后的血栓预防治疗。其目的将是证明GHA在监测抗凝治疗在降低因手术而风险较高的癌症患者中的VTE发病率方面的有效性。这项研究是HemoSonics和弗吉尼亚大学医学院的合作成果。