SepsisSIC-BURN-JAAM2NCT07914205
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
An observational study of Sepsis and Sepsis-induced Coagulopathy, run by Center for Traumatology and Major Burns, Ben Arous at 1 site in Tunisia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Sepsis-induced Coagulopathy, Disseminated Intravascular Coagulation
- What is being tested?
- 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
- How many people
- 150 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Aug 2026to 31 Dec 2027
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site, 1 recruiting
- Recruiting
Trauma and Burn Center of Tunis
Tunis, 2092
Amenne ALOUINI, M.D, 0021628700112, amenne.alouini@fmt.utm.tn
amenne.alouini@fmt.utm.tn
About this study
Official title: Early Detection and Kinetic Trajectory of Sepsis-Induced Coagulopathy in Severe Burn Patients: A Prospective Single-Center Observational Cohort Study
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.
Read the detailed 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.
- Conditions
- Sepsis, Sepsis-induced Coagulopathy, Disseminated Intravascular Coagulation, Burns, Thermal Injury
- Being tested
- 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
- Keywords
- SEPSIS, Burn Injury, Sepsis-Induced Coagulopathy, Disseminated Intravascular Coagulation, JAAM-2 Score, ISTH Score, SOFA Score, Intensive Care, Immunothrombosis
- Medical subject headings
- Sepsis, Disseminated Intravascular Coagulation, Burns, Thromboinflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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) measuredDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| Severe Burn Patients with Sepsis | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0 to Day 10 (evaluated at Day 0, H48, Day 4, Day 6, Day 8, and Day 10)
Secondary outcomes (6)
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]).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Day 0 and Day 2 (H48)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Aug 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Center for Traumatology and Major Burns, Ben Arous
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amenne ALOUINI, Center for Traumatology and Major Burns, Ben Arous
- Investigators
- Amenne ALOUINI, M.D., Principal investigator, Trauma and Burn Center of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914205
- Sponsor's protocol ID
- REANIM-BRULE-JAAM2
- Other IDs
- Comité d'Éthique CTGB
- Acronym
- SIC-BURN-JAAM2
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Kinetic Trajectory of Sepsis-Induced Coagulopathy in Severe Burn Patients: A Prospective Single-Center Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07914205
- Acronym / sponsor ID
- SIC-BURN-JAAM2 / REANIM-BRULE-JAAM2
- Conditions
- Sepsis, Sepsis-induced Coagulopathy, Disseminated Intravascular Coagulation, Burns, Thermal Injury
- Keywords
- SEPSIS, Burn Injury, Sepsis-Induced Coagulopathy, Disseminated Intravascular Coagulation, JAAM-2 Score, ISTH Score, SOFA Score, Intensive Care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Center for Traumatology and Major Burns, Ben ArousUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe Burn Patients with Sepsis | – | 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) measuredAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) measuredSimultaneous 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 test | Severe Burn Patients with Sepsis |
Primary outcome
Diagnostic Accuracy and Early Kinetic Trajectory of the JAAM-2 Score
Time frame: Day 0 to Day 10 (evaluated at Day 0, H48, Day 4, Day 6, Day 8, and Day 10)
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
6 secondary outcomes
Area Under the Receiver Operating Characteristic Curve (AUROC) of the JAAM-2 Score Compared to ISTH Criteria
Time frame: Day 0 to Day 10
Change in Sequential Organ Failure Assessment (SOFA) Score From Baseline to Day 7
Time frame: Baseline (Day 0) to Day 7
Percentage of Participants With Clinical Sepsis Non-Control at Day 7
Time frame: Day 7
Association Between JAAM-2 Kinetic Trajectories and 28-Day All-Cause Mortality
Time frame: Day 28
Absolute Value of Neutrophil-to-Lymphocyte Ratio (NLR) at Day 0 and H48
Time frame: Day 0 and Day 2 (H48)
Absolute Value of Platelet-to-Lymphocyte Ratio (PLR) at Day 0 and H48
Time frame: Day 0 and Day 2 (H48)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amenne ALOUINI, M.D. principal investigator
Trauma and Burn Center of Tunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Sepsis-induced Coagulopathy, run by Center for Traumatology and Major Burns, Ben Arous at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amenne ALOUINI, M.D. (+21628700112, amenne.alouini@fmt.utm.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy and Early Kinetic Trajectory of the JAAM-2 Score (time frame: Day 0 to Day 10 (evaluated at Day 0, H48, Day 4, Day 6, Day 8, and Day 10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.