Can recombinant human thrombomodulin increase survival among patients with severe septic-induced disseminated intravascular coagulation: a single-centre, open-label, randomised controlled trial

Objective: To determine whether treatment with recombinant human thrombomodulin (rhTM) increases survival among severe septic patients with sepsis-induced disseminated intravascular coagulation (DIC) Design: Single-center, open-label, randomized controlled trial Setting: Single tertiary hospital Participant: 92 severe septic patients with sepsis-induced DIC Interventions: Patients with DIC scores ≥4, as defined by the Japanese Association of Acute Medicine, were diagnosed with DIC. Randomization was performed by the envelope method. The treatment group (rhTM group, n = 47) was intravenously treated with rhTM within 24 h of admission (day 0), and the control group (n = 45) did not receive any anti-coagulants, except in cases of deep venous thrombosis and pulmonary embolism. Primary and secondary measurements: Data were collected on days 0 (admission), 1, 2, 3, 5, 7, and 10. The primary outcome was survival at 28 and 90 days. The secondary endpoints comprised changes in DIC scores, p...研究目的：明确重组人血栓调节蛋白（recombinant human thrombomodulin, rhTM）治疗是否可提升合并脓毒症诱导弥散性血管内凝血（disseminated intravascular coagulation, DIC）的重症脓毒症患者的存活率。 试验设计：单中心、开放标签随机对照试验。 试验场所：单家三级医院。 研究对象：92例合并脓毒症诱导DIC的重症脓毒症患者。 干预方案：以日本急性医学会制定的DIC诊断标准，即DIC评分≥4分作为纳入诊断依据，采用信封法实施随机分组。治疗组（rhTM组，n=47）于入院后24小时内（第0天）静脉给予rhTM治疗；对照组（n=45）除合并深静脉血栓与肺栓塞的病例外，不接受任何抗凝治疗。 主要与次要观测指标：于入院第0、1、2、3、5、7、10天采集相关数据。主要结局指标为28天及90天存活率；次要结局指标包括DIC评分变化、……