NCT06891599

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Region Stockholm · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-03-24
• Last updated: 2025-03-24

Locations

1 site across 1 country: Sweden