A randomized, controlled, multicenter trial of the effects of antithrombin on disseminated intravascular coagulation in patients with sepsis.
A randomized, controlled, multicenter trial of the effects of antithrombin on disseminated intravascular coagulation in patients with sepsis.
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DOI：
10.1186/cc13163
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发表时间：
2013-12-16
期刊：
影响因子：
--
通讯作者：
Japanese Association for Acute Medicine Disseminated Intravascular Coagulation (JAAM DIC) Study Group for the JAAM DIC Antithrombin Trial (JAAMDICAT)
中科院分区：
文献类型：
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作者：
Gando S;Saitoh D;Ishikura H;Ueyama M;Otomo Y;Oda S;Kushimoto S;Tanjoh K;Mayumi T;Ikeda T;Iba T;Eguchi Y;Okamoto K;Ogura H;Koseki K;Sakamoto Y;Takayama Y;Shirai K;Takasu O;Inoue Y;Mashiko K;Tsubota T;Endo S;Japanese Association for Acute Medicine Disseminated Intravascular Coagulation (JAAM DIC) Study Group for the JAAM DIC Antithrombin Trial (JAAMDICAT)
为了验证这一假设，即给予抗凝血酶浓缩物可改善弥散性血管内凝血（DIC），使败血症患者从DIC中恢复并获得更好的结局，我们在三级医院的13个重症监护中心进行了一项前瞻性、随机对照、多中心试验。我们在这项研究中纳入了60例败血症和抗凝血酶水平为50 - 80%的DIC患者。参与研究的患者被随机分配到抗凝血酶组，接受抗凝血酶治疗，剂量为30 IU/kg/天，持续3天，或对照组，不接受任何干预。主要疗效终点为第3天DIC恢复。采用意向治疗方法进行分析。根据日本急性医学协会（JAAM）评分系统诊断DIC。在第0天和第3天测量全身炎症反应综合征（SIRS）评分、血小板计数和凝血和纤溶总体标志物。与对照组相比，抗凝血酶治疗组第3天DIC评分显著降低，DIC恢复率更好。轻微出血并发症的发生率未增加，未观察到与抗凝血酶治疗相关的大出血。血小板计数显著增加;然而，抗凝血酶不影响第3天的序贯器官衰竭评估（SOFA）评分或凝血和纤溶标志物。中等剂量的抗凝血酶可改善DIC评分，从而提高DIC的恢复率，而无任何出血风险。UMIN临床试验登记研究（UMIN-CTR）UMIN 000000882
To test the hypothesis that the administration of antithrombin concentrate improves disseminated intravascular coagulation (DIC), resulting in recovery from DIC and better outcomes in patients with sepsis, we conducted a prospective, randomized controlled multicenter trial at 13 critical care centers in tertiary care hospitals. We enrolled 60 DIC patients with sepsis and antithrombin levels of 50 to 80% in this study. The participating patients were randomly assigned to an antithrombin arm receiving antithrombin at a dose of 30 IU/kg per day for three days or a control arm treated with no intervention. The primary efficacy end point was recovery from DIC on day 3. The analysis was conducted with an intention-to-treat approach. DIC was diagnosed according to the Japanese Association for Acute Medicine (JAAM) scoring system. The systemic inflammatory response syndrome (SIRS) score, platelet count and global markers of coagulation and fibrinolysis were measured on day 0 and day 3. Antithrombin treatment resulted in significantly decreased DIC scores and better recovery rates from DIC compared with those observed in the control group on day 3. The incidence of minor bleeding complications did not increase, and no major bleeding related to antithrombin treatment was observed. The platelet count significantly increased; however, antithrombin did not influence the sequential organ failure assessment (SOFA) score or markers of coagulation and fibrinolysis on day 3. Moderate doses of antithrombin improve DIC scores, thereby increasing the recovery rate from DIC without any risk of bleeding in DIC patients with sepsis. UMIN Clinical Trials Registry (UMIN-CTR) UMIN000000882
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影响因子：
38.9
作者：
Baudo, F;Caimi, TM;Calori, G
通讯作者：
Calori, G
影响因子：
15.1
作者：
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影响因子：
120.7
作者：
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3.6
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通讯作者：
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38.9
作者：
Eisele, B;Lamy, M;Delvos, U
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Delvos, U