Early detection of sepsis-related blood clotting problems in severe burn patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study follows adults with severe thermal burns (>20% TBSA) who develop a first septic episode in the ICU. From day 0 to day 10, researchers will repeatedly measure coagulation parameters to calculate the JAAM-2 score and track its progression, comparing its performance with other DIC/SIC scoring systems. The study also examines whether early JAAM-2 scores can predict organ dysfunction, sepsis control, and 28-day mortality, while evaluating immunothrombotic ratios. Data collection includes serial clinical evaluations and laboratory tests over a 28-day period, within a single burn center in Tunis.

Why it matters

Who can join: the full rules

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

Where it's running

• Trauma and Burn Center of Tunis
  Tunis, Tunisia Recruiting

Study contacts

• Principal investigator: Amenne ALOUINI, M.D. — Trauma and Burn Center of Tunis
• Study coordinator: Amenne ALOUINI, M.D.
• Email: amenne.alouini@fmt.utm.tn
• Phone: +21628700112

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.