Recombinant soluble thrombomodulin for postoperative disseminated intravascular coagulation.

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.

Materials And 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.