Trial · NCT07914205
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
NCT07914205, Recruiting, Center for Traumatology and Major Burns, Ben Arous
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients. Trials, record NCT07914205. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07914205
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
- NCT number
- NCT07914205
- Status
- Recruiting
- Enrollment
- 150 participants, estimated
- Lead sponsor
- Center for Traumatology and Major Burns, Ben Arous
- Conditions
- Sepsis, Sepsis-induced Coagulopathy, Disseminated Intravascular Coagulation, Burns, Thermal Injury
- Interventions
- 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
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | 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 |
| Secondary | Area Under the Receiver Operating Characteristic Curve (AUROC) of the JAAM-2 Score Compared to ISTH Criteria | Day 0 to Day 10 | 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 \[perfect discrimination\]). |
| Secondary | Change in Sequential Organ Failure Assessment (SOFA) Score From Baseline to Day 7 | Baseline (Day 0) 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). |
| Secondary | Percentage of Participants With Clinical Sepsis Non-Control at Day 7 | 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. |
| Secondary | Association Between JAAM-2 Kinetic Trajectories and 28-Day All-Cause Mortality | Day 28 | 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 |
| Secondary | Absolute Value of Neutrophil-to-Lymphocyte Ratio (NLR) at Day 0 and H48 | Day 0 and Day 2 (H48) | Evaluation of the immunothrombotic response quantified by the absolute Neutrophil-to-Lymphocyte Ratio, calculated as absolute neutrophil count divided by absolute lymphocyte count. |
| Secondary | Absolute Value of Platelet-to-Lymphocyte Ratio (PLR) at Day 0 and H48 | Day 0 and Day 2 (H48) | Evaluation of the immunothrombotic response quantified by the absolute Platelet-to-Lymphocyte Ratio, calculated as absolute platelet count divided by absolute lymphocyte count. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07914205
GET https://conductscience.org/api/trials/v1/NCT07914205/registered