Overview
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.
Description
Background and Rationale:
Severe burn trauma triggers a profound systemic inflammatory response that interacts closely with the hemostatic system. When complicated by sepsis, patients rapidly develop microvascular thrombosis and consumption coagulopathy, leading to multi-organ failure and death. Standard diagnostic criteria for disseminated intravascular coagulation often lack sensitivity during the initial hyperinflammatory phase. The JAAM-2 score incorporates platelet counts (or kinetic drop), prothrombin time/INR, and D-dimer/FDP levels without relying on systemic inflammatory response syndrome (SIRS) criteria, making it a promising tool for early detection in burn ICU settings. Study Objectives:Primary Objective: To evaluate the diagnostic accuracy and early kinetic evolution (Day 0 to Day 10) of the JAAM-2 score for identifying sepsis-induced coagulopathy in adult severe burn patients. Secondary Objectives:Compare the diagnostic performance of the JAAM-2 score against the ISTH "Overt DIC" and ISTH-SIC scores. Assess the predictive value of baseline (Day 0) and H48 JAAM-2 scores for organ dysfunction progression (SOFA score) and clinical sepsis non-control at Day 7. Evaluate the association between kinetic trajectories of the JAAM-2 score and 28-day all-cause mortality. Validate the diagnostic performance of immunothrombotic ratios (neutrophil-to-lymphocyte ratio \[NLR\] and platelet-to-lymphocyte ratio \[PLR\]) during the initial septic phase. Study Design and Workflow:
This is a prospective, single-center, observational cohort study conducted in a specialized Burn Intensive Care Unit. Eligible adult patients (≥18 years) with thermal burns covering \>20% TBSA diagnosed with a first episode of sepsis (according to American Burn Association 2007 criteria) will be included. Data collection occurs at specific time points: Baseline (Day 0 / T0), H48 (Day 2), Day 4, Day 6, Day 8, and Day 10. Baseline Assessment (Day 0): Demographics (age, sex), burn characteristics (% TBSA, smoke inhalation), burn severity scores (ABSI, UBS), and delay between burn injury and sepsis onset. Serial Biological and Clinical Monitoring (D0, H48, D4, D6, D8, D10):Organ failure assessment: Sequential Organ Failure Assessment (SOFA) score, vasopressor requirements (norepinephrine maximum dose), and mechanical ventilation parameters. Coagulation panel: Platelet count, Prothrombin Time (PT / INR), D-dimers (or FDP), and Fibrinogen. Inflammatory and hematological markers: Leukocytes, Absolute Neutrophil Count, Absolute Lymphocyte Count, NLR, and PLR. Coagulopathy scores: Simultaneous calculation of JAAM-2, ISTH "Overt DIC", and ISTH-SIC scores. Day 7 Evaluation: Assessment of clinical sepsis control status (controlled vs. uncontrolled, defined by persistent septic shock requiring norepinephrine or emergency surgical source control). Day 28 Follow-up: Vital status (alive/deceased), total duration of mechanical ventilation, ICU length of stay, and occurrence of major thrombotic (deep vein thrombosis / pulmonary embolism) or major bleeding events.
Eligibility
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
