RecruitingNCT06891599

ROTEM in Sepsis Trauma Outcome in Intensive Care

Advanced Coagulation Diagnostics Using ROTEM and Standard Coagulation Tests in Hospitalized Patients With Sepsis or Trauma - A Prospective Observational Study (ROSTIC - ROTEM for Sepsis and Trauma Induced Coagulopathy)


Sponsor

Region Stockholm

Enrollment

600 participants

Start Date

Nov 1, 2024

Study Type

OBSERVATIONAL

Conditions

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 (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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria6

  • 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

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Locations(1)

Region Stockholm

Stockholm, Sweden

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NCT06891599


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