ROTEM in Sepsis Trauma Outcome in Intensive Care (ROSTIC)

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)

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Mattias Günther, MD PhD; Phone Number: +46812361000; Email: mattias.gunther@regionstockholm.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Region Stockholm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients in Stockhiolm Region

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Region Stockholm

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Sepsis; Trauma; ROTEM; Coagulopathy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Hematologic Diseases; Hemorrhagic Disorders; Wounds and Injuries; Sepsis; Toxemia; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: 2022-07157-01; FoUI-985360 (Other Grant/Funding Number: Region Stockholm ALF)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

At this time, individual participant data (IPD) will not be shared due to privacy concerns, ethical considerations, and regulatory restrictions. The study involves sensitive patient data, including coagulation profiles and clinical outcomes, which are subject to strict data protection laws and institutional guidelines within Region Stockholm.

Additionally, data will be pseudoanonymized and stored on secure research servers, with access limited to the study team. While aggregate results will be published in peer-reviewed journals, sharing of raw IPD requires specific ethical and legal approvals, which are not currently in place for unrestricted access.

However, data access requests for collaborative research may be considered on a case-by-case basis, subject to approval by the relevant ethics committees and data protection authorities.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No