Safety of recombinant thrombomodulin during percutaneous transhepatic gallbladder drainage in patients with biliary tract infections and disseminated intravascular coagulation: A retrospective cohort study

Biliary tract infections complicated by disseminated intravascular coagulation (DIC) require urgent source control and careful correction of coagulopathy. Recombinant thrombomodulin (rTM) is widely used for DIC in Japan, but its perioperative safety in patients undergoing percutaneous transhepatic gallbladder drainage (PTGBD) has not been fully clarified. This study aims to determine whether perioperative rTM administration increases the risk of PTGBD-related adverse events (AEs) in patients with biliary tract infections and DIC. This retrospective cohort study included patients with biliary tract infections and DIC who underwent PTGBD between January 2017 and August 2025 at a single tertiary center. Patients who died within 24 hours or who initiated rTM more than 3 days after PTGBD were excluded. The primary outcome was PTGBD-related AEs. Secondary outcomes included bleeding-related AEs, 28-day mortality, DIC resolution on Day 7, and intensive care unit length of stay. Bayesian sensitivity analyses and stratified analyses based on concomitant therapies were also performed. A total of 30 patients were included (19 received rTM and 11 did not). PTGBD-related AEs occurred in 21.1% of the rTM group and 18.2% of the non-rTM group. No bleeding-related AEs were observed in either group. Bayesian analysis estimated upper 95% credible limits of 2.8% and 3.1% for PTGBD-related bleeding in the rTM and non-rTM groups, respectively. Secondary outcomes - including 28-day mortality, DIC resolution on Day 7, and intensive care unit stay - showed no meaningful differences between groups, and stratified analyses yielded consistent results. Perioperative rTM use during PTGBD was not associated with an increased incidence of PTGBD-related AEs, including bleeding. These findings indicate that rTM may be administered without substantial additional procedural risk in patients with biliary tract infections and DIC, although larger studies are needed to validate its safety.