ROTEM in Sepsis Trauma Outcome in Intensive Care

Recruiting now

Conditions studied: Sepsis - to Reduce Mortality in the Intensive Care Unit, Trauma Coagulopathy

In brief

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 (DIC) and trauma-induced coagulopathy (TIC) in hospitalized patients with sepsis or trauma. Standard coagulation tests and ROTEM measurements will be collected and analyzed in relation to clinical outcomes.

Key facts

Study ID

NCT06891599

Run by

Region Stockholm

People needed

600

Starts

2024-11-01

Expected to finish

2026-12-31

Last updated by the study team

2025-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Region Stockholm — Stockholm, Sweden (enrolling)

Full record on ClinicalTrials.gov

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