Data from: Can recombinant human thrombomodulin increase survival among patients with severe septic-induced disseminated intravascular coagulation: a single-center, open-label, randomized 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, platelet counts, D-dimer, antithrombin III (ATIII), and C-reactive protein (CRP) levels, and Sequential Organ Failure Assessment (SOFA) scores. All analyses were conducted on an intent-to-treat basis.
Main Results: The 28-day survival rates were 84 and 83% in the control and rhTM groups, respectively (p = 0.745, log rank test). The 90-day survival rates were 73% and 72% in the control and rhTM groups, respectively (p = 0.94, log rank test). Meanwhile, the rates of recovery from DIC (<4) were significantly higher in the rhTM group than in the control group (p = 0.001, log rank test). Relative change from baseline of D-dimer levels were significantly lower in the rhTM group than in the control group, on day 3 and 5.
Conclusion: rhTM treatment decreased D-dimer levels and facilitated DIC recovery in severe septic patients with sepsis-induced DIC. However, the treatment did not improve survival in this cohort.

研究目标：明确重组人血栓调节蛋白（recombinant human thrombomodulin, rhTM）治疗是否可提升脓毒症诱发弥散性血管内凝血（disseminated intravascular coagulation, DIC）重症脓毒症患者的生存率。
试验设计：单中心、开放标签、随机对照试验。
研究场景：单所三级甲等医院。
研究对象：92例脓毒症诱发弥散性血管内凝血的重症脓毒症患者。
干预措施：按照日本急性医学会制定的诊断标准，DIC评分≥4分者即可诊断为弥散性血管内凝血。采用信封法进行随机分组。治疗组（rhTM组，n=47）于入院24小时内（第0天）静脉输注rhTM；对照组（n=45）除深静脉血栓及肺栓塞病例外，不接受任何抗凝治疗。
主要与次要观测指标：分别于入院第0天、第1、2、3、5、7、10天收集数据。主要结局指标为28天及90天生存率；次要结局指标包括DIC评分、血小板计数、D-二聚体、抗凝血酶Ⅲ（antithrombin III, ATIII）与C反应蛋白（C-reactive protein, CRP）水平的变化，以及序贯器官衰竭评估（Sequential Organ Failure Assessment, SOFA）评分。所有分析均遵循意向性治疗原则。
主要结果：对照组与rhTM组的28天生存率分别为84%与83%（log-rank检验，p=0.745）；90天生存率分别为73%与72%（log-rank检验，p=0.94）。与此同时，rhTM组的DIC缓解率（评分<4分）显著高于对照组（log-rank检验，p=0.001）。在第3天与第5天时，rhTM组的D-二聚体水平较基线的相对变化显著低于对照组。
结论：对于脓毒症诱发弥散性血管内凝血的重症脓毒症患者，rhTM治疗可降低D-二聚体水平并促进DIC缓解，但未能提升该队列患者的生存率。