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BACKGROUND	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 .
METHODS	We enrolled 60 DIC patients with sepsis and antithrombin levels of 50 to 80 % in this study .
METHODS	The participating patients were randomly assigned to an antithrombin arm receiving antithrombin at a dose of 30IU/kg per day for three days or a control arm treated with no intervention .
METHODS	The primary efficacy end point was recovery from DIC on day 3 .
METHODS	The analysis was conducted with an intention-to-treat approach .
METHODS	DIC was diagnosed according to the Japanese Association for Acute Medicine ( JAAM ) scoring system .
METHODS	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 .
RESULTS	The incidence of minor bleeding complications did not increase , and no major bleeding related to antithrombin treatment was observed .
RESULTS	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	Moderate doses of antithrombin improve DIC scores , thereby increasing the recovery rate from DIC without any risk of bleeding in DIC patients with sepsis .
BACKGROUND	UMIN Clinical Trials Registry ( UMIN-CTR ) UMIN000000882 .

