6/29/23, 11:42 PM SCARLET Pathway Feedback Search Clinical Topics Home Studies SCARLET SCARLET Disease Sepsis and septic shock Trial question What is the effect of recombinant human soluble thrombomodulin in patients with sepsis-associated coagulopathy? Study design Multi-center Double blinded RCT Population Characteristics of study participants 44.9% female N = 816 55.1% male 816 patients (363 female, 437 male) Inclusion criteria: ICU adult patients with sepsis-associated coagulopathy and concomitant cardiovascular and/or respiratory failure Key exclusion criteria: platelets < 30,000/ mm , known allergy to ART-123 or any components of the drug product, history of head trauma, or other acute trauma with an increased risk of bleeding within 3 months Interventions N=395 recombinant human soluble thrombomodulin (an intravenous bolus or a 15-minute infusion of 0.06 mg/kg with a maximum dose of 6 mg/day, once daily for 6 consecutive days) N=405 placebo (matching placebo once daily for 6 consecutive days) https://web.pathway.md/studies/rec4k6l7rs3qEE2kz 1/2 6/29/23, 11:42 PM SCARLET Pathway Primary outcome Death from all causes at day 28 29.4 % 29.4 26.8 22.0 % 14.7 % 7.3 % No significant difference 0.0 % Recombinant human soluble thrombomodulin Placebo No significant difference in death from all causes at day 28 (26.8% vs. 29.4%; ARD -2.55, 95% CI -3.68 to 8.77) Secondary outcomes No significant difference in median plasma concentration of D-dimer at day 6 (1129.5 ng/mL vs. 1649 ng/mL; AD -519.5 ng/mL, 95% CI -1039.89 to 0.89) No significant difference in median plasma concentration of prothrombin fragment F1.2 at day 6 (309.6 pmol/L vs. 393.2 pmol/L; AD -83.6 pmol/L, 95% CI -167.34 to 0.14) No significant difference in median plasma concentration of thrombin-antithrombin complex at day 6 (5.2 ng/mL vs. 7.8 ng/mL; AD -2.6 ng/mL, 95% CI -5.2 to 0) Safety outcomes No significant differences in adverse events, serious adverse events, serious major bleeding event. Conclusion In ICU adult patients with sepsis-associated coagulopathy and concomitant cardiovascular and/or respiratory failure, recombinant human soluble thrombomodulin was not superior to placebo with respect to death from all causes at day 28. Reference Jean-Louis Vincent, Bruno Francois, Igor Zabolotskikh et al. Effect of a Recombinant Human Soluble Thrombomodulin on Mortality in Patients With Sepsis-Associated Coagulopathy: The SCARLET Randomized Clinical Trial. JAMA. 2019 May 28;321(20):1993-2002. Open reference URL https://web.pathway.md/studies/rec4k6l7rs3qEE2kz 2/2