ROTEM in Sepsis Trauma Outcome in Intensive Care

NCT06891599 | Recruiting

• 2 other identifiers: 2022-07157-01FoUI-985360
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Sepsis; ROTEM; Trauma; Coagulopathy

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion, an average of 2 years

Study Arms (3)

Trauma

Trauma alarm activated at hospital admission New Injury Severity Score (NISS) \> 15 Transfer to hospital within 7 days of trauma with NISS \> 15

Sepsis

Meeting Sepsis-3 criteria Receipt of intravenous beta-lactam or aminoglycoside antibiotics within 48 hours of admission

Control

Patients undergoing elective surgery without expected coagulopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients in Stockhiolm Region

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (1)

Region Stockholm

Stockholm, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Sepsis; Wounds and Injuries; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Mattias Günther, MD PhD

CONTACT

+46812361000; mattias.gunther@regionstockholm.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 24, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

SE (1)