Clinical Research Directory

Safflower (Carthamus Tinctorius L.) Granules for Sepsis-associated Coagulopathy

Sepsis is a life-threatening condition in which infection triggers widespread inflammation and blood clotting abnormalities. Many patients with sepsis develop coagulopathy (impaired blood clotting), which contributes to organ damage and death. Safflower (Carthamus tinctorius L.) is a traditional Chinese medicine herb with documented anticoagulant, anti-platelet, and blood vessel-protective properties. This randomized, double-blind, placebo-controlled trial will enroll 210 adult patients with sepsis-associated coagulopathy at Ruijin Hospital. Participants will be randomly assigned to one of three groups: high-dose safflower granules (equivalent to 9 g of raw herb daily), medium-dose safflower granules (equivalent to 6 g of raw herb daily), matching placebo (equivalent to 0.6 g of raw herb daily for blinding). The granules are dissolved in 50 mL of warm water and given through a nasogastric tube once daily for 7 days, in addition to standard sepsis treatment. The primary outcome is the improvement in the SOFA score (a measure of organ function) at 14 days. Secondary outcomes include DIC scores, coagulation tests, endothelial injury and platelet markers, inflammatory markers, 28-day mortality, length of ICU and hospital stay, and adverse events. The study is funded by Ruijin Hospital as an investigator-initiated trial.

EARLY DIAGNOSIS OF SEPTIC DIC

Disseminated Intravascular Coagulation is a severe complication of septic shock, associated with high mortality, whose diagnosis relies on complex scores that are rarely used in practice. Preliminary studies have shown that increased neutrophil fluorescence is associated with Disseminated Intravascular Coagulation and could reflect NETosis, a key mechanism of immunothrombosis. This study aims to validate neutrophil fluorescence measured on the SthemA 801 analyzer, alone or integrated into an artificial intelligence model, as an early, reliable, and routinely usable biomarker for the diagnosis of septic Disseminated Intravascular Coagulation.

Fluorescent Leukocytes as a Marker of Early Sepsis/Severity

Sepsis is a medical emergency whose prognosis depends on the early identification of patients at risk of septic shock, but the tools available in the Emergency Department remain insufficient. Neutrophils, key players in immunothrombosis, show alterations detectable via cell fluorescence (e.g., NE-SFL), which are strongly correlated with the severity of sepsis and septic DIC. The FLAMES study will evaluate, from the time of admission to the Emergency Department, the relevance of neutrophil fluorescence as an early biomarker of severity, either alone or integrated into an AI model based on the multiparametric data from the SthemA 801, with comparison to the Sysmex XN. It aims to address an unmet clinical need: the immediate stratification of the risk of severe forms of sepsis. Hypothesis: higher initial fluorescence will identify patients at risk of organ failure, septic shock, or DIC.