Blood Coagulation Monitoring at the Point of Care

护理点凝血监测

• 批准号: 8761491
• 负责人: Seemantini K Nadkarni
• 金额: $ 43.5万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8761491
• 关键词: Acute; Address; Agonist; Anemia; Blood; Blood Coagulation Disorders; Blood Coagulation Factor; Blood Platelets; Blood coagulation; Blood specimen; Cardiac Surgery procedures; Caring; Cessation of life; Chronic Disease; Clinical; Clinical Management; Clinical Research; Coagulants; Coagulation Process; Correlative Study; Critical Illness; Deep Vein Thrombosis; Defect; Detection; Development; Devices; Diagnosis; Disease; Disease Management; Drops; Early Diagnosis; Early identification; Equilibrium; Evaluation; Event; Fibrin; Fibrinogen; Fibrinolysis; Goals; Hand; Hemorrhage; Hospitals; Image; Individual; Laboratories; Lasers; Lead; Life; Measurement; Measures; Mechanics; Metric; Microprocessor; Monitor; Motion; Multiple Organ Failure; Operative Surgical Procedures; Optics; Organ failure; Outcome; Pathway interactions; Patients; Pattern; Phase; Platelet aggregation; Predisposition; Property; Pulmonary Embolism; Rheology; Risk; Sampling; Shock; Solutions; Source; Speed; Techniques; Technology; Testing; Thrombelastography; Thrombosis; Time; Tissues; Touch sensation; Transfusion; Translating; Trauma; Whole Blood; Work; base; blood resource; crosslink; improved; injured; innovation; instrument; light scattering; novel; novel strategies; operation; particle; point of care; public health relevance; sensor; tool; trauma care; treatment response; validation studies; viscoelasticity

DESCRIPTION: The goal of this project is to develop and validate a hand-held sensor for the rapid and comprehensive assessment of coagulation status in patients. Impaired blood coagulation or coagulopathy, results from several conditions associated with severe trauma, surgery or illness, and can cause life-threatening bleeding or thrombotic disorders. Deficient coagulation can lead to 'hypocoagulable' states resulting in uncontrolled bleeding, which may cause severe anemia, shock and multiple organ failure. In other cases, coagulation defects may manifest as 'hypercoagulable' states, causing increased clotting that can result in potentially fatal complications such as deep vein thrombosis and pulmonary embolism. During surgery, trauma care and chronic disease management, clinicians often encounter the challenging task of maintaining a precarious balance between bleeding and coagulation. In order to achieve optimal outcome, the early detection of coagulation defects and coagulation monitoring during therapy is therefore essential. Unfortunately, the diagnosis and treatment monitoring of impaired coagulation is currently problematic because of the long turn-around time of standard laboratory tests. Our proposal directly addresses the unmet clinical need to develop and translate a hand-held, portable coagulation sensor, termed Optical Thromboelastography (OTEG) for point of care use. The technique involves placing a few drops of blood in a small cartridge. A laser source illuminates the blood sample and a CMOS camera images laser speckle patterns reflected from the sample over time. By analyzing laser speckle intensity fluctuations in real-time, we can measure blood viscoelastic properties during coagulation and recover information about multiple coagulation metrics. The OTEG device will also provide the capability to measure platelet aggregation in real- time to diagnose impaired platelet function in patients. As a result, using a single portable device with a few drops of blood, OTEG can achieve the comprehensive assessment of multiple parameters: clotting time, clot viscoelasticity and formation rate, fibrinogen, fibrinolysis and platelet function, within a few minutes. To validate the device, we wil perform studies to test the accuracy of OTEG via comparison with standard thromboelastography and laboratory tests. In the final phase of our work, we will conduct a clinical study to evaluate the utility of OTEG for coagulation monitoring in patients at the point f care.

描述：该项目的目标是开发和验证手持式传感器，用于快速、全面地评估患者的凝血状态。血液凝固受损或凝血病是由与严重创伤、手术或疾病相关的几种情况引起的，可能导致危及生命的出血或血栓性疾病。凝血功能不足会导致“低凝血”状态，从而导致失控的出血，从而可能导致严重贫血、休克和多器官衰竭。在其他情况下，凝血缺陷可能表现为“高凝”状态，导致凝血增加，从而可能导致潜在致命的并发症，例如深静脉血栓形成和肺栓塞。在手术、创伤护理和慢性病管理过程中，临床医生经常遇到维持出血和凝血之间不稳定平衡的挑战性任务。因此，为了获得最佳结果，早期发现凝血缺陷并在治疗期间进行凝血监测至关重要。不幸的是，由于标准实验室测试的周转时间较长，目前凝血功能受损的诊断和治疗监测存在问题。我们的提案直接解决了未满足的临床需求，即开发和翻译一种手持式便携式凝血传感器，称为光学血栓弹力图 (OTEG)，供护理点使用。该技术涉及将几滴血液放入一个小墨盒中。激光源照射血液样本，CMOS 相机对样本随时间反射的激光散斑图案进行成像。通过实时分析激光散斑强度波动，我们可以测量凝血过程中的血液粘弹性特性并恢复有关多个凝血指标的信息。 OTEG 设备还将提供实时测量血小板聚集的能力，以诊断患者血小板功能受损。因此， 使用单个便携式设备和几滴血液，OTEG可以在几分钟内实现多个参数的综合评估：凝血时间、凝块粘弹性和形成率、纤维蛋白原、纤溶和血小板功能。为了验证该设备，我们将进行研究，通过与标准血栓弹力图和实验室测试进行比较来测试 OTEG 的准确性。在我们工作的最后阶段，我们将进行一项临床研究，以评估 OTEG 在现场护理患者凝血监测中的效用。