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Recruiting NCT07914205

Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients

Conditions: Sepsis, Sepsis-induced Coagulopathy, Disseminated Intravascular Coagulation, Burns, Thermal Injury

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 150
Sponsor: Center for Traumatology and Major Burns, Ben Arous

Location: Trauma and Burn Center of Tunis Tunis

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.

Eligibility Criteria

Inclusion Criteria: * Adult patient (aged 18 years or older). * Severe thermal burn with Total Body Surface Area (TBSA) \> 20% * Confirmed diagnosis of a first episode of secondary sepsis during the ICU stay according to the American Burn Association (ABA 2007) criteria Exclusion Criteria: * Early mortality occurring within 72 hours following sepsis diagnosis * Massive transfusion of blood products (packed red blood cells, fresh frozen plasma, or platelets) within 12 hours prior to initial baseline sampling (T0) * Pre-existing therapeutic anticoagulant therapy prior to inclusion (e.g., VKAs, DOACs, therapeutic heparin) * Pre-existing constitutional coagulopathy or severe chronic liver disease (Child-Pugh Class C) * Pre-existing chronic kidney disease * Pregnant women

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07914205). StuddyBuddy aggregates publicly available trial information.