Abstract | INTRODUCTION: METHODS: 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. RESULTS:
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. CONCLUSIONS: TRIAL REGISTRATION: UMIN Clinical Trials Registry (UMIN-CTR) UMIN000000882.
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Authors | 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, Japanese Association for Acute Medicine Disseminated Intravascular Coagulation (JAAM DIC) Study Group for the JAAM DIC Antithrombin Trial (JAAMDICAT) |
Journal | Critical care (London, England)
(Crit Care)
Vol. 17
Issue 6
Pg. R297
(Dec 16 2013)
ISSN: 1466-609X [Electronic] England |
PMID | 24342495
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Aged
- Antithrombins
(administration & dosage, therapeutic use)
- Blood Coagulation
(drug effects)
- Disseminated Intravascular Coagulation
(drug therapy, etiology)
- Drug Administration Schedule
- Female
- Fibrinolysis
(drug effects)
- Gabexate
(administration & dosage, therapeutic use)
- Humans
- Male
- Platelet Count
- Prospective Studies
- Sepsis
(complications)
- Treatment Outcome
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