Assessment of bleeding in patients with disseminated intravascular coagulation after receiving surgery and recombinant human soluble thrombomodulin: A cohort study using a database

We aimed to investigate the incidence of bleeding-related adverse events (AEs) among patients with disseminated intravascular coagulation (DIC) receiving recombinant thrombomodulin (rTM) and those receiving other DIC treatments, the incidence by type of surgery, and the incidence when either blood transfusion or a hemostatic procedure was administered to treat DIC. In this cohort study, data were obtained from a large medical database (22 centers in Japan). The primary endpoint was the incidence rate of bleeding-related AEs by type of surgery. The secondary endpoint was the incidence rate of bleeding-related AEs based on whether blood transfusion or a hemostatic procedure was administered after the day of DIC treatment. In total, 4234 propensity score-matched patients were included in the main analysis (2117 patients each in the rTM and non-rTM groups). In the rTM and non-rTM groups, respectively, the incidence of bleeding-related AEs was 18.8% and 24.8% (p <0.001; risk ratio [RR] 0.757, 95% confidence interval [CI] 0.674–0.849), among patients requiring any type of surgery; 15.0% and 19.5% (p = 0.0001; RR 0.769, 95% CI 0.673–0.879) in patients requiring blood transfusion or a hemostatic procedure after the day of DIC treatment; 10.2% and 11.6% (p = 0.4470; RR 0.879, 95% CI 0.630–1.226) in patients undergoing hepatic, biliary, or pancreatic surgery; 24.3% and 25.4% (p = 0.6439; RR 0.955, 95% CI 0.786–1.160) in patients undergoing gastrointestinal surgeries; and 18.5% and 30.1% (p = 0.0001; RR 0.614, 95% CI 0.481–0.782) in patients undergoing cardiac or cardiovascular surgery. Our findings suggest that rTM treatment for Japanese postsurgical patients who develop DIC was associated with significantly fewer bleeding-related AEs compared with those receiving other DIC treatments.