Using ROTEM analysis to improve outcomes in sepsis and trauma patients
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)
This study is testing if a special blood test can help doctors spot early signs of serious blood clotting issues in patients with sepsis or trauma to improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06891599 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include trauma patients with a New Injury Severity Score greater than 15 and sepsis patients meeting Sepsis-3 criteria.
Not a fit: Patients under 18 years old or those with ongoing anticoagulant treatment or life-threatening illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and better management of coagulopathy in sepsis and trauma patients, potentially reducing mortality rates.
How similar studies have performed: Other studies have shown promise in using ROTEM analysis for coagulation assessment, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Stockholm
- Region Stockholm — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Mattias Günther, MD PhD
- Email: mattias.gunther@regionstockholm.se
- Phone: +46812361000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.