Blood Coagulation Monitoring at the Point of Care

护理点凝血监测

• 批准号: 9303442
• 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 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9303442
• 关键词: Acute; Address; Agonist; Anemia; Anticoagulants; Antiplatelet Drugs; 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; 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; Fibrinolytic Agents; Goals; Hand; Hemorrhage; Hospitals; Impairment; Individual; Laboratories; Lasers; Laser Speckle Imaging; Lead; Life; Measurement; Measures; Mechanics; Microprocessor; Modulus; Monitor; Motion; Multiple Organ Failure; Operative Surgical Procedures; Optics; Organ failure; Outcome; Pathway interactions; Patient-Focused Outcomes; Patients; Pattern; Phase; Platelet aggregation; Predisposition; Property; Pulmonary Embolism; Rheology; Risk; Sampling; Shock; Source; Speed; Techniques; Technology; Testing; Thrombelastography; Thrombophilia; 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; portability; 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：该项目的目的是开发和验证手持传感器，以快速，全面评估患者的凝血状态。血液凝结或凝血病受损，是由于严重的创伤，手术或疾病而引起的几种疾病，可能导致生命的出血或血栓性疾病。不足的凝血会导致“低凝”状态，导致不受控制的出血，这可能导致严重的贫血，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，可能导致潜在的致命并发症，例如深静脉血栓形成和肺栓塞。在手术，创伤护理和慢性疾病管理期间，临床医生经常遇到具有挑战性的任务，即在出血和凝结之间保持不稳定的平衡。为了获得最佳结果，必须在治疗过程中早期发现凝血缺陷和凝血监测。不幸的是，由于标准实验室测试的转弯时间很长，因此凝血受损的诊断和治疗监测目前是有问题的。我们的建议直接解决了未满足的临床需求，以开发和翻译一种可用于护理点的手持式凝血传感器，称为光直动物血栓形象（OTEG）。该技术涉及将几滴血液放在一个小弹药筒中。激光源可照亮血液样本和CMOS摄像头图像激光斑点图案随着时间的流逝反射。通过实时分析激光斑点强度波动，我们可以在凝结过程中测量血液粘弹性特性，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，以诊断患者的血小板功能受损。因此， 使用单滴血液的单个便携式设备，OTEG可以在几分钟内在几分钟内实现多个参数的全面评估：凝结时间，凝块粘弹性和形成速率，纤维蛋白原，纤维蛋白溶解和血小板功能。为了验证设备，我们将进行研究，以通过比较标准血栓射击和实验室测试来测试OTEG的准确性。在工作的最后阶段，我们将进行一项临床研究，以评估OTEG在F Poine F护理中对患者进行凝血监测的效用。