NCT06891599 ROTEM in Sepsis Trauma Outcome in Intensive Care
| NCT ID | NCT06891599 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Stockholm |
| Condition | Sepsis - to Reduce Mortality in the Intensive Care Unit |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2024-11-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06891599 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis - to Reduce Mortality in the Intensive Care Unit. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06891599 currently recruiting?
Yes, NCT06891599 is actively recruiting participants. Contact the research team at mattias.gunther@regionstockholm.se for enrollment information.
Where is the NCT06891599 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT06891599 clinical trial?
NCT06891599 is sponsored by Region Stockholm. The trial plans to enroll 600 participants.