Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07914205

Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients

Sponsor: Center for Traumatology and Major Burns, Ben Arous

View on ClinicalTrials.gov

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). 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.

Official title: Early Detection and Kinetic Trajectory of Sepsis-Induced Coagulopathy in Severe Burn Patients: A Prospective Single-Center Observational Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2026-08-01

Completion Date

2027-12-31

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

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).

Locations (1)

Trauma and Burn Center of Tunis

Tunis, Tunisia