An observational study in Sepsis, Sepsis-induced Coagulopathy and Disseminated Intravascular Coagulation, sponsored by Center for Traumatology and Major Burns, Ben Arous. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Center for Traumatology and Major Burns, Ben Arous · Observational
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.
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.
1,956 studies on the registry are indexed under Sepsis; 477 are open to participants now.
This study's planned enrollment of 150 is close to the median of 160 across 964 observational studies indexed under Sepsis.
Browse Sepsis studies →Center for Traumatology and Major Burns, Ben Arous is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Adult patients with severe thermal burns (>20% TBSA) admitted to the Burn Intensive Care Unit who develop a first episode of secondary sepsis during their ICU stay
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Exclusion Criteria:
Adult ICU patients (aged ≥18 years) with severe thermal burns (\>20% Total Body Surface Area) who develop a first episode of sepsis during their ICU stay, defined according to the American Burn Association (ABA 2007) criteria.
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
Simultaneous evaluation of the International Society on Thrombosis and Haemostasis "Overt DIC" score and Sepsis-Induced Coagulopathy (ISTH-SIC) score at the same sampling timepoints (Day 0 to Day 10).
Diagnostic Accuracy and Early Kinetic Trajectory of the JAAM-2 Score
Evaluation of the diagnostic performance (sensitivity, specificity, ROC-AUC) and serial kinetic changes of the revised Japanese Association for Acute Medicine (JAAM-2) score (cutoff ≥ 4 points) for detecting sepsis-induced coagulopathy in severe burn patients
Time frame: Day 0 to Day 10 (evaluated at Day 0, H48, Day 4, Day 6, Day 8, and Day 10)
Area Under the Receiver Operating Characteristic Curve (AUROC) of the JAAM-2 Score Compared to ISTH Criteria
Diagnostic discrimination of the JAAM-2 score (cutoff ≥ 4) evaluated against the ISTH Overt DIC score (cutoff ≥ 5) and ISTH-SIC score (cutoff ≥ 4), quantified by the AUROC value (ranging from 0.5 \[no discrimination\] to 1.0 \[perfect discrimination\]).
Time frame: Day 0 to Day 10
Change in Sequential Organ Failure Assessment (SOFA) Score From Baseline to Day 7
Absolute change in total SOFA score, calculated as (Day 7 SOFA score minus Day 0 SOFA score) to assess multi-organ failure progression. Total SOFA score ranges from 0 (normal) to 24 (severe organ failure).
Time frame: Baseline (Day 0) to Day 7
Percentage of Participants With Clinical Sepsis Non-Control at Day 7
Proportion of participants experiencing clinical non-control of sepsis at Day 7, defined as persistent septic shock requiring vasopressor support or emergency surgical re-intervention.
Time frame: Day 7
Association Between JAAM-2 Kinetic Trajectories and 28-Day All-Cause Mortality
Evaluation of the association between kinetic trajectory profiles of the JAAM-2 score across the first 10 days and overall patient mortality at Day 28
Time frame: Day 28
Absolute Value of Neutrophil-to-Lymphocyte Ratio (NLR) at Day 0 and H48
Evaluation of the immunothrombotic response quantified by the absolute Neutrophil-to-Lymphocyte Ratio, calculated as absolute neutrophil count divided by absolute lymphocyte count.
Time frame: Day 0 and Day 2 (H48)
Absolute Value of Platelet-to-Lymphocyte Ratio (PLR) at Day 0 and H48
Evaluation of the immunothrombotic response quantified by the absolute Platelet-to-Lymphocyte Ratio, calculated as absolute platelet count divided by absolute lymphocyte count.
Time frame: Day 0 and Day 2 (H48)
Plan to share: Undecided — The policy regarding the sharing of de-identified individual participant data has not been finalized yet and will be determined prior to study completion or manuscript publication.
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Started Aug 2026 (actual). Primary completion is estimated for Dec 2027, 16 months after the start.
Of 410 non-industry observational studies under Sepsis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's planned 16 months is below that.
Counting every sponsor, half of 456 studies reached it within 29 months; a quarter within 12 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Center for Traumatology and Major Burns, Ben Arous