ROTEM in Sepsis Trauma Outcome in Intensive Care (ROSTIC)

Region Stockholm

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06891599

FoUI-985360 (Other Grant/Funding Number)

2022-07157-01

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

600 participants in 3 patient groups

Trauma

Description:

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

Sepsis

Description:

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

Control

Description:

Patients undergoing elective surgery without expected coagulopathy