ROTEM in Sepsis Trauma Outcome in Intensive Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Trauma

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

No interventions assigned to this group

Sepsis

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

No interventions assigned to this group

Control

Patients undergoing elective surgery without expected coagulopathy

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No