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Multicenter Study
. 2018 Oct 8;13(10):e0205146.
doi: 10.1371/journal.pone.0205146. eCollection 2018.

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

Takuhiro Yamaguchi  1 , Yukio Kitajima  2 , Yasuhiro Miyauchi  2 , Kazutoshi Izawa  2 , Masakazu Tanaka  2 , Masatada Hirata  2 , Yasunari Sadatsuki  2 , Yoshihiro Ogawa  2
Affiliations
Multicenter Study

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

Takuhiro Yamaguchi et al. PLoS One. .

Abstract

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.

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Conflict of interest statement

This study was funded by Asahi Kasei Pharma Corporation. Takuhiro Yamaguchi has received honoraria (lecture fees) from Asahi Kasei Pharma Corporation. Asahi Kasei Pharma Corporation purchased data from MDV and provided those data to the study researchers. Yukio Kitajima, Yasuhiro Miyauchi, Kazutoshi Izawa, Masakazu Tanaka, Masatada Hirata, Yasunari Sadatsuki, and Yoshihiro Ogawa are employed by CAC Croit Corporation. CAC Croit Corporation, as a study secretariat, has received funding from Asahi Kasei Pharma Corporation. There are no patents, products in development, or marketed products to declare. This does not alter our adherence to all PLOS ONE policies on sharing data and materials, as detailed online in the Guide for Authors.

Figures

Fig 1
Fig 1. Flow diagram illustrating patient enrollment (all types of surgery).
MDV, Medical Datavision; DIC, disseminated intravascular coagulation; rTM, recombinant thrombomodulin; ICH, intracranial hemorrhage.
See this image and copyright information in PMC

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