An observational study in Sepsis - to Reduce Mortality in the Intensive Care Unit and Trauma Coagulopathy, sponsored by Region Stockholm. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-24.
Sponsored by Region Stockholm · Observational
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 600 is above the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →Region Stockholm is the lead sponsor of 121 studies on the registry; 69 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients in Stockhiolm Region
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 () Age \<18 years
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Trauma alarm activated at hospital admission New Injury Severity Score (NISS) \> 15 Transfer to hospital within 7 days of trauma with NISS \> 15
Meeting Sepsis-3 criteria Receipt of intravenous beta-lactam or aminoglycoside antibiotics within 48 hours of admission
Patients undergoing elective surgery without expected coagulopathy
Detection of abnormal coagulation clusters via PCA of ROTEM in trauma and sepsis patients
Detection of abnormal coagulation clusters via PCA of ROTEM in trauma and sepsis patients
Time frame: Through study completion, an average of 2 years
Plan to share: Undecided — At this time, individual participant data (IPD) will not be shared due to privacy concerns, ethical considerations, and regulatory restrictions. The study involves sensitive patient data, including coagulation profiles and clinical outcomes, which are subject to strict data protection laws and institutional guidelines within Region Stockholm. Additionally, data will be pseudoanonymized and stored on secure research servers, with access limited to the study team. While aggregate results will be published in peer-reviewed journals, sharing of raw IPD requires specific ethical and legal approvals, which are not currently in place for unrestricted access. However, data access requests for collaborative research may be considered on a case-by-case basis, subject to approval by the relevant ethics committees and data protection authorities.
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