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Life sciences · Observational Study
ClinicalTrials.gov · November 3, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07914205). This is a study registration, not published results. Lead sponsor: Center for Traumatology and Major Burns, Ben Arous. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 150 participants (ESTIMATED). Conditions: Sepsis, Sepsis-induced Coagulopathy, Disseminated Intravascular Coagulation, Burns, Thermal Injury. Interventions: DIAGNOSTIC_TEST: Prospective calculation and kinetic monitoring of the revised Japanese Association for Acute Medicine (JAAM-2) score using biological parameters (platelet count/kinetics, PT/INR, D-dimer/FDP) measured. Primary outcome measures: Diagnostic Accuracy and Early Kinetic Trajectory of the JAAM-2 Score , Day 0 to Day 10 (evaluated at Day 0, H48, Day 4, Day 6, Day 8, and Day 10). Brief summary: Sepsis is a major and life-threatening complication in patients with severe burn injuries, frequently progressing to sepsis-induced coagulopathy (SIC) and disseminated intravascular coagulation (DIC). Early detection of coagulopathy in burn patients remains challenging due to the massive background inflammatory response triggered by the thermal injury itself. The primary objective of this prospective observational study is to evaluate the diagnostic performance and early kinetic trajectory (from Day 0 to Day 10) of the revised Japanese Association for Acute Medicine (JAAM-2) score for detecting sepsis-induced coagulopathy in severe burn patients. Adult patients with severe thermal burns (\>20% total body surface area) who develop a first episode of sepsis in the intensive care unit (ICU) will be monitored over a 28-day period. Sequential clinical evaluations and laboratory tests will be performed at Day 0 (T0), H48 (Day 2), Day 4, Day 6, Day 8, and Day 10. The study will compare the JAAM-2 score with established coagulopathy scores (ISTH Overt DIC and ISTH-SIC) and analyze its association with organ dysfunction, sepsis control at Day 7, and 28-day overall mortality.