title: Recombinant soluble thrombomodulin for postoperative disseminated intravascular coagulation.
abstract: BACKGROUND
  Thrombomodulin is a thrombin receptor on the endothelial cell surface that plays an important role in the regulation of intravascular coagulation. The purpose of this study was to evaluate the efficacy and safety of treatment with recombinant human soluble thrombomodulin (rhTM) for patients with septic-disseminated intravascular coagulation (DIC) associated with gastroenterological surgery.
  
  
  METHODS
  From April 2011-September 2013, 201 patients with DIC associated with gastroenterological surgery were treated in 16 institutions in Kumamoto, Japan. The patients were diagnosed according to the Japanese Association for Acute Medicine DIC scoring system. The clinical course, mortality rate at 28 d, and adverse events were evaluated retrospectively.
  
  
  RESULTS
  Forty-five patients were excluded because they did not meet the Japanese Association for Acute Medicine DIC criteria or had an insufficient duration of drug administration. Thus, 156 patients were analyzed. Of these patients, 107 received rhTM at the discretion of the attending surgeon and 49 did not. The most common reason for surgery in both groups was peritonitis due to perforation of the colon. Within 7 d, the platelet count, prothrombin time-international normalized ratio, DIC score, neutrophil count, and C-reactive protein level significantly improved in the rhTM group compared with those in the control. Treatment with rhTM was significantly associated with reduced inhospital mortality at 28 d. The incidence of adverse events did not differ between the two groups.
  
  
  CONCLUSIONS
  Therapy with rhTM may be associated with reduced inhospital mortality in patients with septic DIC associated with gastroenterological surgery without increasing adverse events.
authors.affiliation: Department of Gastroenterological Surgery, Kumamoto University Graduate School of Medical Sciences, Kumamoto, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Hashimoto
authors.affiliation: Department of Gastroenterological Surgery, Kumamoto University Graduate School of Medical Sciences, Kumamoto, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Chikamoto
authors.affiliation: Department of Surgery, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.
authors.forename: Nobutomo
authors.initials: N
authors.lastname: Miyanari
authors.affiliation: Department of Surgery, Kumamoto Saishunso National Hospital, Koshi, Japan.
authors.forename: Chitoshi
authors.initials: C
authors.lastname: Ohara
authors.affiliation: Department of Surgery, Kumamoto Social Insurance General Hospital, Yatsushiro, Japan.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Kuramoto
authors.affiliation: Department of Surgery, Kumamoto Rosai Hospital, Yatsushiro, Japan.
authors.forename: Kei
authors.initials: K
authors.lastname: Horino
authors.affiliation: Department of Surgery, Arao Municipal Hospital, Arao, Japan.
authors.forename: Hisami
authors.initials: H
authors.lastname: Ohshima
authors.affiliation: Department of Gastroenterological Surgery, Kumamoto University Graduate School of Medical Sciences, Kumamoto, Japan. Electronic address: hdobaba@kumamoto-u.ac.jp.
authors.forename: Hideo
authors.initials: H
authors.lastname: Baba
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use*; D013505:Digestive System Surgical Procedures; D004211:Disseminated Intravascular Coagulation / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D004334:Drug Administration Schedule; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000188:drug therapy* / Q000401:mortality; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D018180:Thrombomodulin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D011994:Recombinant Proteins; C546931:THBD protein, human; D018180:Thrombomodulin
keywords: Complication; Disseminated intravascular coagulation; Gastroenterological operation; Thrombomodulin