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
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Region Stockholm
RECRUITING
Stockholm
Contact Information
Primary
Mattias Günther, MD PhD
mattias.gunther@regionstockholm.se
+46812361000
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 600
Treatments
Trauma
Trauma alarm activated at hospital admission New Injury Severity Score (NISS) \> 15 Transfer to hospital within 7 days of trauma with NISS \> 15
Sepsis
Meeting Sepsis-3 criteria Receipt of intravenous beta-lactam or aminoglycoside antibiotics within 48 hours of admission
Control
Patients undergoing elective surgery without expected coagulopathy
Sponsors
Leads: Region Stockholm

This content was sourced from clinicaltrials.gov