ROTEM in Sepsis Trauma Outcome in Intensive Care

Region Stockholm600 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Sepsis - to Reduce Mortality in the Intensive Care Unit Trauma Coagulopathy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Region Stockholm

Stockholm, Sweden

RECRUITING

Outcomes

Primary Outcomes

Detection of abnormal coagulation clusters via PCA of ROTEM in trauma and sepsis patients

Time frame: Through study completion, an average of 2 years

Central Contacts

Mattias Günther, MD PhD

CONTACT

+46812361000 mattias.gunther@regionstockholm.se

Data from ClinicalTrials.gov

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