ROTEM in Sepsis Trauma Outcome in Intensive Care

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)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06891599

Acronym

ROSTIC

Enrollment

600

Registered

2025-03-24

Start date

2024-11-01

Completion date

2026-12-31

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Sepsis, ROTEM, Trauma, Coagulopathy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Detection of abnormal coagulation clusters via PCA of ROTEM in trauma and sepsis patients	Through study completion, an average of 2 years	Detection of abnormal coagulation clusters via PCA of ROTEM in trauma and sepsis patients

Countries

Sweden

Contacts

Primary ContactMattias Günther, MD PhD

mattias.gunther@regionstockholm.se+46812361000

Outcome results