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Search / Trial NCT06891599

ROTEM in Sepsis Trauma Outcome in Intensive Care

Launched by REGION STOCKHOLM · Mar 20, 2025

Trial Information

Current as of September 08, 2025

Recruiting

Keywords

Sepsis Rotem Trauma Coagulopathy

ClinConnect Summary

This clinical trial, titled "ROTEM in Sepsis Trauma Outcome in Intensive Care," is investigating how a specialized test called ROTEM can help doctors find early signs of serious blood clotting problems in patients with sepsis (a severe infection) or trauma (injury). The goal is to see if this test can improve patient care and potentially reduce death rates in the Intensive Care Unit (ICU). Researchers will compare the results of the ROTEM tests with standard blood tests and look at how well patients recover.

To participate in this study, patients must meet certain criteria. For trauma patients, they need to have a significant injury score and be admitted to the hospital within a week of their trauma. Sepsis patients must meet specific infection criteria and have received certain antibiotics shortly after arriving at the hospital. There is also a control group of patients undergoing planned surgery who do not have clotting issues. Participants can expect to have their blood tested using ROTEM and standard methods, and researchers will closely monitor their health outcomes. This trial is currently recruiting patients aged 65 and older and aims to gather valuable information that could improve treatment for future patients.

Gender

ALL

Eligibility criteria

  • 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

About Region Stockholm

Region Stockholm is a leading healthcare authority committed to advancing medical research and improving patient care through innovative clinical trials. As a sponsor, Region Stockholm collaborates with hospitals, research institutions, and industry partners to facilitate the development of new therapies and treatment protocols. With a focus on quality, safety, and ethical standards, the organization aims to enhance health outcomes for the diverse population of Stockholm and beyond, leveraging cutting-edge research to translate scientific discoveries into effective healthcare solutions.

Locations

Stockholm, , Sweden

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported