ROTEM in Sepsis Trauma Outcome in Intensive Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sepsis - to Reduce Mortality in the Intensive Care Unit, Trauma Coagulopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
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.
Primary outcome measures
- Detection of abnormal coagulation clusters via PCA of ROTEM in trauma and sepsis patients [Time frame: Through study completion, an average of 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Region Stockholm — Stockholm
Identifiers
NCT: NCT06891599 · 2022-07157-01 · FoUI-985360