ROTEM in Sepsis Trauma Outcome in Intensive Care

Recruiting

• Conditions: Sepsis - to Reduce Mortality in the Intensive Care Unit; Trauma Coagulopathy

• Registration Number: NCT06891599
• Lead Sponsor: Region Stockholm

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-24
• Last Update Posted: 2025-03-24
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of abnormal coagulation clusters via PCA of ROTEM in trauma and sepsis patients	Through study completion, an average of 2 years	Detection of abnormal coagulation clusters via PCA of ROTEM in trauma and sepsis patients

Trial Locations

Locations (1)

Region Stockholm; 🇸🇪 Stockholm, Sweden