Integrated Coagulation Sensing to Predict Hemorrhage and Guide Transfusions

集成凝血传感来预测出血并指导输血

• 批准号: 10204092
• 负责人: Seemantini K Nadkarni
• 金额: $ 79.08万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10204092
• 关键词: Acute Lung Injury; Address; Algorithms; Allogenic; Award; Blood; Blood Coagulation Disorders; Blood Coagulation Factor; Blood Component Transfusion; Blood Platelets; Blood Transfusion; Blood specimen; Cardiac; Cardiac Surgery procedures; Clinical; Coagulation Process; Complex; Complication; Critical Illness; Defect; Development; Devices; Dose; Drops; Event; Fibrin; Fibrinolysis; Generations; Goals; Hand; Health Care Costs; Healthcare; Hematocrit procedure; Hemoglobin; Hemorrhage; Hemostatic function; Hospitals; Hour; Iatrogenesis; Impairment; Individual; Intelligence; Intensive Care Units; Kidney Failure; Laboratories; Laser Speckle Imaging; Lasers; Lead; Life; Measures; Microprocessor; Modeling; Modulus; Monitor; Motion; Operative Surgical Procedures; Optics; Organ failure; Outcome; Pathway interactions; Patient-Focused Outcomes; Patients; Pattern; Phase; Plasma; Platelet Count measurement; Procedures; Property; Prothrombin time assay; Recommendation; Repeat Surgery; Reporting; Resources; Rheology; Risk; Sampling; Savings; Severities; Societies; Source; System; Techniques; Testing; Thoracic Surgeon; Thrombin; Time; Tissues; Touch sensation; Transfusion; Unit of Measure; Vascular blood supply; Whole Blood; Work; base; blood product; cardiac intensive care unit; cohort; cost; crosslink; improved; indexing; individual patient; infection risk; innovation; instrument; light scattering; meter; mortality; novel; novel strategies; operation; particle; platelet function; point of care; polymerization; predictive modeling; rapid testing; tool; validation studies; viscoelasticity; wasting

ABSTRACT The goal of this project is to develop an integrated coagulation instrument approach for use at the point-of-care to predict bleeding events and tailor blood component transfusion after cardiac surgery. Severe bleeding, frequently a result of impaired coagulation or coagulopathy, occurs in over 50% of patients after complex cardiac surgeries. Multiple factors including the depletion of clotting factors, impaired platelet function and the systemic activation of fibrinolytic pathways contribute to the development of coagulopathy. To manage defective coagulation, blood components are transfused to correct bleeding abnormalities. Inadequate or delayed transfusion can lead to life-threatening blood loss and organ failure, while overuse of allogenic blood may cause acute lung injury, renal failure and increased mortality after cardiac surgery. In order to achieve optimal outcome and save lives, clinical tools that can rapidly predict major bleeding following cardiac surgery are essential. Unfortunately, laboratory tests are ineffective in the context of rapidly changing coagulation conditions in critically-ill cardiac patients, resulting in transfusion triggers that are often imprecise, inadequate and in many cases, clinically unnecessary. Together, these factors pose detrimental complications for patients, and place a large burden on healthcare costs by wasting a scarce resource leading to blood product shortage for patients in need. This dire situation has prompted a Class I recommendation by the Society of Thoracic Surgeons for tailoring transfusion decisions via point-of-care coagulation tests that are supplemented with integrated transfusion algorithms. Our proposal directly addresses this recommendation. Here, we propose a novel approach termed iCoagLab that measures multiple coagulation parameters within less than 10 minutes at the bedside to identify patients at an elevated risk of bleeding after cardiac surgery, tailor transfusion requirements and monitor hemostasis during treatment. The technique involves placing a few drops of whole blood in a small cartridge. A laser source illuminates the blood sample and a camera images laser speckle patterns reflected from the sample over time. By analyzing laser speckle intensity fluctuations during coagulation, we can simultaneously quantify multiple coagulation metrics including prothrombin time, activated clotting time, thrombin generation rate, fibrin polymerization, fibrinolysis, and platelet function. The optical device will be supplemented by an algorithm that combines information from multiplexed coagulation parameters to predict bleeding severity and identify transfusion strategies tailored to the individual patient. In the final phase of our work, we will conduct studies to evaluate the accuracy and utility of the new iCoagLab approach to predict bleeding risk and transfusion requirements in patients admitted to the cardiac ICU following surgery.

抽象的 该项目的目标是开发一种集成凝血仪器方法，供在 即时预测心脏手术后出血事件并调整血液成分输注。 超过 50% 的患者会出现严重出血，通常是由于凝血功能受损或凝血障碍所致 复杂的心脏手术后。多种因素，包括凝血因子耗竭、血小板受损 纤溶途径的功能和系统激活有助于凝血病的发生。到 控制凝血缺陷，输入血液成分以纠正出血异常。不足 或延迟输血可能导致危及生命的失血和器官衰竭，而过度使用同种异体输血 血液可能导致急性肺损伤、肾功能衰竭以及心脏手术后死亡率增加。为了 实现最佳结果并挽救生命，可以快速预测心脏骤停后大出血的临床工具 手术是必不可少的。不幸的是，实验室测试在快速变化的背景下是无效的 危重心脏病患者的凝血状况，导致输血触发通常不精确， 不充分，并且在许多情况下临床上没有必要。这些因素共同造成有害的并发症 对于患者来说，浪费稀缺资源导致血液成为医疗费用的沉重负担 对于有需要的患者来说，产品短缺。这种严峻的情况促使了 I 级建议 胸外科医生协会通过护理点凝血测试来调整输血决策 辅以集成输血算法。我们的提案直接解决了这一建议。 在这里，我们提出了一种称为 iCoagLab 的新方法，可以测量多个凝血参数 在床边不到 10 分钟即可识别心脏手术后出血风险较高的患者， 调整输血要求并在治疗期间监测止血情况。该技术涉及放置一些 将全血滴在小盒中。激光源照亮血液样本和相机图像 随着时间的推移从样品反射的激光散斑图案。通过分析激光散斑强度波动 在凝血过程中，我们可以同时量化多个凝血指标，包括凝血酶原时间、 活化凝血时间、凝血酶生成速率、纤维蛋白聚合、纤维蛋白溶解和血小板功能。这 光学装置将辅以结合多重凝血信息的算法 参数来预测出血严重程度并确定适合个体患者的输血策略。在 在我们工作的最后阶段，我们将进行研究以评估新 iCoagLab 的准确性和实用性 预测入住心脏 ICU 患者的出血风险和输血需求的方法 外科手术。

项目成果

Imaging the dynamics and microstructure of fibrin clot polymerization in cardiac surgical patients using spectrally encoded confocal microscopy.

使用光谱编码共聚焦显微镜对心脏手术患者的纤维蛋白凝块聚合的动力学和微观结构进行成像。

• DOI: 10.1002/ajh.26217
• 发表时间: 2021
• 期刊: American journal of hematology
• 影响因子: 12.8
• 作者: Tshikudi,DianeM;Simandoux,Olivier;Kang,Dongkyun;VanCott,ElizabethM;Andrawes,MichaelN;Yelin,Dvir;Nadkarni,SeemantiniK
• 通讯作者: Nadkarni,SeemantiniK

Speckle rheological spectroscopy reveals wideband viscoelastic spectra of biological tissues.

散斑流变光谱揭示了生物组织的宽带粘弹性光谱。

• DOI: 10.1101/2023.06.08.544037
• 发表时间: 2023
• 期刊: bioRxiv : the preprint server for biology
• 作者: Leartprapun,Nichaluk;Zeng,Ziqian;Hajjarian,Zeinab;Bossuyt,Veerle;Nadkarni,SeemantiniK
• 通讯作者: Nadkarni,SeemantiniK

Comprehensive Coagulation Profiling at the Point-of-Care Using a Novel Laser-Based Approach.

使用新型激光方法在护理点进行全面的凝血分析。

• DOI: 10.1055/s-0039-1683842
• 发表时间: 2019
• 期刊: Seminars in thrombosis and hemostasis
• 影响因子: 5.7
• 作者: Nadkarni,SeemantiniK