Efficacy and Safety of Recombinant Human Soluble Thrombomodulin in Patients With Sepsis-Induced Disseminated Intravascular Coagulation After Emergency Surgery.

Introduction Recombinant human soluble thrombomodulin (rhsTM) is a therapeutic agent for sepsis-induced disseminated intravascular coagulation (DIC) and is reported to be associated with bleeding events. Although several studies on rhsTM have been reported, the safety and efficacy of rhsTM for sepsis-induced DIC after emergency laparotomy remain controversial. In this study, we aimed to investigate the efficacy, safety, and bleeding complications of rhsTM in patients with sepsis-induced DIC following emergency abdominal surgery. Methods In this retrospective observational study, we reviewed the data of patients who underwent emergency surgery for gastrointestinal necrosis and perforation and received rhsTM for sepsis-induced DIC at a single center between January 2014 and December 2023. We evaluated the incidence rate of bleeding complications associated with rhsTM treatment, clinical characteristics, and changes in Japanese Association for Acute Medicine (JAAM) DIC scores. Patients with DIC were identified as having the JAAM DIC diagnostic criteria (DIC score ≥4). Results We analyzed a total of 32 patients with sepsis-induced DIC. The APACHE II (Acute Physiology and Chronic Health Evaluation II) score at admission to the intensive care unit was 20. A total of 46.9% of the patients had poor renal function with CKD (chronic kidney disease), classified based on KDIGO (Kidney Disease: Improving Global Outcomes) stage 4 or higher, and 37.5% were on regular hemodialysis. A total of 59.4% of the patients received antithrombotic therapy. The JAAM DIC score was significantly ameliorated from the first day of rhsTM administration (5.3) to days 5-7 of rhsTM administration (3.3) (p < 0.0001). A total of 75% of the patients had a HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Use) score, an indicator of bleeding risk, of 3 or higher. The mortality rate in the whole cohort was 37.5%. Patients were also classified into the following groups: HAS-BLED score ≥3 (n = 24) and <3 (n = 8), and survivors (n = 20) and non-survivors (n = 12). No perioperative bleeding complications were observed. Conclusion rhsTM was not associated with an increased incidence of bleeding complications, even in patients with sepsis-induced DIC following emergency abdominal surgery and in critically ill patients with poor renal function or those receiving antithrombotic therapy. rhsTM is a safe and effective anticoagulant for the management of sepsis-induced DIC after emergency surgery and is clinically feasible.