Status:
RECRUITING
ROTEM in Sepsis Trauma Outcome in Intensive Care
Lead Sponsor:
Region Stockholm
Conditions:
Sepsis - to Reduce Mortality in the Intensive Care Unit
Trauma Coagulopathy
Eligibility:
All Genders
18+ years
Brief Summary
This prospective observational study aims to investigate the ability of advanced ROTEM analysis using Principal Component Analysis (PCA) to detect early signs of disseminated intravascular coagulation...
Eligibility Criteria
Inclusion
- Trauma patients:
- Trauma alarm activated at hospital admission New Injury Severity Score (NISS) \> 15 Transfer to hospital within 7 days of trauma with NISS \> 15
- Sepsis patients:
- Meeting Sepsis-3 criteria Receipt of intravenous beta-lactam or aminoglycoside antibiotics within 48 hours of admission
- Control group:
- Patients undergoing elective surgery without expected coagulopathy
Exclusion
- Trauma patients:
- Isolated chronic subdural hematoma No underlying traumatic event despite trauma alarm Age \<18 years
- Sepsis patients:
- Age \<18 years
- Control patients:
- Ongoing anticoagulant treatment Life-threatening illness (ASA IV-V) Age \<18 years
Key Trial Info
Start Date :
November 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06891599
Start Date
November 1 2024
End Date
December 31 2026
Last Update
March 24 2025
Active Locations (1)
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1
Region Stockholm
Stockholm, Sweden