Abstract
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
Highlights
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
Characteristics of the study population The primary efficacy population consisted of 60 patients who were randomly assigned in equal populations of 30 to either the control group or the antithrombin group; two patients in the antithrombin group were associated with protocol violations
The patients were well matched at study entry for age, sex and acute physiology and chronic health evaluation (APACHE) Acute physiology and chronic health evaluation II (II), systemic inflammatory response syndrome (SIRS), sequential organ failure assessment (SOFA) and DIC scores (Table 3)
Summary
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. The results of antithrombin treatment in patients with sepsis, severe sepsis and septic shock suggest that replacement therapy can reduce mortality [4,5,6]. Too small to be confirmative, a meta-analysis reported that sufficiently powered phase III trials are warranted to prove the beneficial effects of antithrombin in the treatment of these patient populations [5]. While several factors may account for the failure of the KyberSept trial to reach the primary end point of reduced mortality in patients with severe sepsis [8,9,10,11], a systematic review and meta-analysis of randomized trials concluded that antithrombin cannot be recommended for critically ill patients, including those with severe sepsis and septic shock [12]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
