Actively Recruiting

Age: 18Years +
All Genders
NCT06891599

ROTEM in Sepsis Trauma Outcome in Intensive Care

Led by Region Stockholm · Updated on 2025-03-24

600

Participants Needed

1

Research Sites

112 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

ROTEM in Sepsis Trauma Outcome in Intensive Care

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Trauma alarm activated at hospital admission
  • New Injury Severity Score (NISS) greater than 15
  • Transfer to hospital within 7 days of trauma with NISS greater than 15
  • Meeting Sepsis-3 criteria for sepsis
  • Receipt of intravenous beta-lactam or aminoglycoside antibiotics within 48 hours of admission for sepsis patients
  • Patients undergoing elective surgery without expected coagulopathy
Not Eligible

You will not qualify if you...

  • Isolated chronic subdural hematoma in trauma patients
  • No underlying traumatic event despite trauma alarm
  • Age under 18 years for trauma and sepsis patients
  • Ongoing anticoagulant treatment for control patients
  • Life-threatening illness classified as ASA IV-V for control patients
  • Age under 18 years for control patients

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Region Stockholm

Stockholm, Sweden

Actively Recruiting

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Research Team

M

Mattias Günther, MD PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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