Data from: New criteria for sepsis-induced coagulopathy (SIC) following the revised sepsis definition: a retrospective analysis of a nationwide survey

OBJECTIVE: Recent clinical studies have shown that anticoagulant therapy might be effective only in specific at-risk subgroups of patients with sepsis and coagulation dysfunction. The definition of sepsis was recently modified and old scoring systems may no longer be proper for the diagnosis of sepsis-associated coagulopathy. The aim of this study was to evaluate prognostic factors in patients diagnosed as sepsis and coagulopathy according to the new sepsis definition and assess their accuracy in comparison to existing models. DESIGN, SETTING AND SUBJECTS: The data set was obtained from a post-marketing survey examining recombinant human soluble thrombomodulin and offered by Japanese Society on Thrombosis and Hemostasis. A total of 1498 patients with sepsis and coagulopathy complications who were treated with recombinant thrombomodulin were analyzed in this study. MAIN OUTCOME MEASURES: The platelet count, prothrombin time (PT) ratio, fibrinogen and fibrin degradation products (FDP), systemic inflammatory response syndrome (SIRS) score, and sequential organ failure assessment (SOFA) score obtained just before the start of treatment were examined in relation to the 28-day mortality rate. RESULTS: The platelet count, PT ratio, and total SOFA were independent predictors of a fatal outcome in a logistic regression model. A sepsis-induced coagulation (SIC) score was defined using the 3 above-mentioned variables with a positivity threshold of 4 points or more. The SIC score predicted higher 28-day mortality rate compared to the Japanese Association for Acute Medicine (JAAM)-DIC score (38.4% vs. 34.7%). CONCLUSIONS: The SIC scoring is based on readily available parameters, is easy to calculate and owns a high predictive value for 28-day mortality. Future studies are warranted to evaluate whether the SIC score may guide the decision to initiate anticoagulant therapy.研究目的：近期临床研究表明，抗凝治疗仅可能对脓毒症合并凝血功能障碍的特定高危患者亚群有效。当前脓毒症定义已完成更新，旧评分系统或不再适用于脓毒症相关凝血病的诊断。本研究旨在评估符合新脓毒症定义的脓毒症合并凝血功能障碍患者的预后因素，并对比现有模型，评估其预测准确性。 研究设计、场景与研究对象：本数据集来源于日本血栓与止血学会（Japanese Society on Thrombosis and Hemostasis）提供的一项重组人可溶性血栓调节蛋白（recombinant human soluble thrombomodulin）上市后调查。本研究共纳入1498例接受重组血栓调节蛋白治疗的脓毒症合并凝血功能障碍并发症患者进行分析。 主要结局指标：本研究分析了治疗开始前即刻采集的血小板计数、凝血酶原时间（prothrombin time, PT）比值、纤维蛋白原及纤维蛋白降解产物（fibrinogen and fibrin degradation products, FDP）、全身炎症反应综合征（systemic inflammatory response syndrome, SIRS）评分以及序贯器官衰竭评估（sequential organ failure assessment, SOFA）评分与28天死亡率的相关性。 研究结果：经Logistic回归分析显示，血小板计数、PT比值及SOFA总评分是患者不良结局的独立预测因素。基于上述三项变量，本研究定义了脓毒症诱导凝血病（sepsis-induced coagulation, SIC）评分，其阳性阈值设定为4分及以上。与日本急性医学会弥散性血管内凝血（JAAM-DIC）评分相比，SIC评分预测的28天死亡率更高（38.4% vs. 34.7%）。 研究结论：SIC评分基于易于获取的临床参数，计算简便，且对28天死亡率具有较高的预测价值。未来仍需开展相关研究，以评估SIC评分是否可指导抗凝治疗的启动决策。