Integrated Coagulation Sensing to Predict Hemorrhage and Guide Transfusions

摘要 该项目的目标是开发一种综合凝血仪器方法，用于 心脏手术后预测出血事件和量身定制成分输血的护理要点。 超过50%的患者会发生严重出血，通常是凝血功能受损或凝血障碍所致。 在复杂的心脏手术后。多种因素，包括凝血因子耗竭、血小板受损 纤溶系统的功能和激活有助于凝血障碍的发生。至 管理有缺陷的凝血，输注血液成分以纠正出血异常。不足之处 或延迟输血会导致危及生命的失血和器官衰竭，而过度使用同种异体 血液可能会导致心脏手术后的急性肺损伤、肾功能衰竭和死亡率增加。为了 实现最佳结局并挽救生命，可快速预测心脏大出血的临床工具 手术是必不可少的。不幸的是，在快速变化的背景下，实验室测试是无效的 危重心脏病患者的凝血状态，导致输血触发往往不准确， 不充分，在许多情况下，在临床上是不必要的。这些因素加在一起，构成了有害的并发症。 ，并浪费导致血液的稀缺资源，从而给医疗成本带来巨大负担 为有需要的病人提供产品短缺。这种可怕的情况促使世界卫生组织提出了I类建议 胸外科医生协会，通过护理点凝血测试定制输血决定 辅以综合输血算法。我们的建议直接涉及这一建议。 在这里，我们提出了一种名为iCoagLab的新方法，它可以测量体内的多种凝血参数 在床边不到10分钟的时间，以确定心脏手术后出血风险增加的患者， 量身定制输血要求，并在治疗期间监测止血情况。这项技术包括将几个 一小盒里的全血。激光光源照射血液样本和摄像机图像 随着时间的推移，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，我们可以同时定量多项凝血指标，包括凝血酶原时间， 活化凝血时间、凝血酶生成率、纤维蛋白聚合、纤溶和血小板功能。这个 光学设备将被一种算法补充，该算法结合了来自多路传输的凝聚的信息 用于预测出血严重程度和确定针对个别患者量身定做的输血策略的参数。在……里面 在我们工作的最后阶段，我们将进行研究，以评估新的iCoagLab的准确性和实用性 预测心脏ICU患者术后出血风险和输血需求的方法 做手术。

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.