Using ROTEM analysis to improve outcomes in sepsis and trauma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates how advanced ROTEM analysis, combined with Principal Component Analysis (PCA), can identify early signs of disseminated intravascular coagulation (DIC) and trauma-induced coagulopathy (TIC) in patients with sepsis or trauma. It will collect and analyze standard coagulation tests and ROTEM measurements to correlate them with clinical outcomes. The goal is to enhance the understanding of coagulation disorders in critically ill patients and potentially improve their management in intensive care settings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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 Criteria:

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's running

• Region Stockholm
  Stockholm, Sweden Recruiting

Study contacts

• Study coordinator: Mattias Günther, MD PhD
• Email: mattias.gunther@regionstockholm.se
• Phone: +46812361000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.