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NCT Number: NCT06891599

ROTEM in Sepsis Trauma Outcome in Intensive Care

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.

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Key information

Conditions

Sepsis - to Reduce Mortality in the Intensive Care Unit Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Trauma Coagulopathy Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Region Stockholm

Stockholm, Sweden

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mattias Günther, MD PhD

CONTACT

[email protected]

+46812361000

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Registry information

Official study 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)

Acronym: ROSTIC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2025
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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