• Satoshi Gando, Daizoh Saitoh, Hiroyasu Ishikura, Masashi Ueyama, Yasuhiro Otomo, Shigeto Oda, Shigeki Kushimoto, Katsuhisa Tanjoh, Toshihiko Mayumi, Toshiaki Ikeda, Toshiaki Iba, Yutaka Eguchi, Kohji Okamoto, Hiroshi Ogura, Kazuhide Koseki, Yuichiro Sakamoto, Yasuhiro Takayama, Kunihiro Shirai, Osamu Takasu, Yoshiaki Inoue, Kunihiro Mashiko, Takaya Tsubota, Shigeatsu Endo, and Japanese Association for Acute Medicine Disseminated Intravascular Coagulation (JAAM DIC) Study Group for the JAAM DIC Antithrombin Trial (JAAMDICAT).
• Crit Care. 2013 Dec 16; 17 (6): R297.

IntroductionTo 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.MethodsWe 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.ResultsAntithrombin 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.ConclusionsModerate doses of antithrombin improve DIC scores, thereby increasing the recovery rate from DIC without any risk of bleeding in DIC patients with sepsis.Trial RegistrationUMIN Clinical Trials Registry (UMIN-CTR) UMIN000000882.

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