1. The Pro position : The SCARLET study (Sepsis Coagulopathy Asahi Recombinant LE Thrombomodulin) required a herculean effort spanning over 6 years from 159 investigative sites across 26 countries to finish this phase 3 trial, testing a recombinant human form of soluble thrombomodulin in sepsis/septic shock [1]. A total of 800 patients were randomised in this double-blind, placebo-controlled trial. Looking on the bright side, this study confirms that soluble thrombomodulin has an excellent safety record in treating septic patients. This adds further evidence of a low incidence of serious bleeding events or other possible toxicities found in safety studies performed in Japan, where soluble thrombomodulin is already available on the market as a treatment for disseminated intravascular coagulation from sepsis-induced coagulopathy [...]
Laterre, P.-F., Levy, M. M., Wittebole, X., Dugernier, T., Francois, B., & Opal, S. M. (2019). Should we continue to test soluble thrombomodulin, or other systemic anticoagulants, as a life-saving therapy for sepsis-induced coagulopathy? Anaesthesia, critical care & pain medicine, 38(5), 419-421. https://doi.org/10.1016/j.accpm.2019.09.003 (Original work published 2019)