RecruitingNot Applicable

ROTEM in Sepsis Trauma Outcome in Intensive Care

Sweden600 participantsStarted 2024-11-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Detection of abnormal coagulation clusters via PCA of ROTEM in trauma and sepsis patients

Timeframe: Through study completion, an average of 2 years

Trial details

NCT IDNCT06891599

SponsorRegion Stockholm

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Mattias Günther, MD PhD

+46812361000 mattias.gunther@regionstockholm.se

View on ClinicalTrials.gov More Sepsis - to Reduce Mortality in the Intensive Care Unit trials