title: A randomized, controlled, multicenter trial of the effects of antithrombin on disseminated intravascular coagulation in patients with sepsis.
abstract: 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. 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
  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.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Gando
authors.forename: Daizoh
authors.initials: D
authors.lastname: Saitoh
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Ishikura
authors.forename: Masashi
authors.initials: M
authors.lastname: Ueyama
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Otomo
authors.forename: Shigeto
authors.initials: S
authors.lastname: Oda
authors.forename: Shigeki
authors.initials: S
authors.lastname: Kushimoto
authors.forename: Katsuhisa
authors.initials: K
authors.lastname: Tanjoh
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Mayumi
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Ikeda
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Iba
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Eguchi
authors.forename: Kohji
authors.initials: K
authors.lastname: Okamoto
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ogura
authors.forename: Kazuhide
authors.initials: K
authors.lastname: Koseki
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Sakamoto
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Takayama
authors.forename: Kunihiro
authors.initials: K
authors.lastname: Shirai
authors.forename: Osamu
authors.initials: O
authors.lastname: Takasu
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Inoue
authors.forename: Kunihiro
authors.initials: K
authors.lastname: Mashiko
authors.forename: Takaya
authors.initials: T
authors.lastname: Tsubota
authors.forename: Shigeatsu
authors.initials: S
authors.lastname: Endo
mesh_terms: D000368:Aged; D000991:Antithrombins / Q000008:administration & dosage / Q000627:therapeutic use*; D001777:Blood Coagulation / Q000187:drug effects; D004211:Disseminated Intravascular Coagulation / Q000188:drug therapy* / Q000209:etiology; D004334:Drug Administration Schedule; D005260:Female; D005342:Fibrinolysis / Q000187:drug effects; D016670:Gabexate / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D008297:Male; D010976:Platelet Count; D011446:Prospective Studies; D018805:Sepsis / Q000150:complications*; D016896:Treatment Outcome
chemical_list: D000991:Antithrombins; D016670:Gabexate