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.

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

All patients in Stockhiolm Region

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.