Assessing blood clotting issues in patients with sepsis and trauma
Official title: Fibrinolysis Resistance in Infection and Trauma
Run by South West Sydney Local Health District · NCT06680180 · Data updated 2026-11-12
This study is testing a new way to identify patients with sepsis or trauma who are at risk for dangerous blood clots and see if new blood-thinning medications can help improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | South West Sydney Local Health District Academic / other |
| Locations | 4 sites (Canberra, Australian Capital Territory and 3 other locations) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | June 1, 2026 |
| Registry record updated | November 8, 2024 |
| Trial ID | NCT06680180 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include critically ill patients admitted to the ICU with clinically suspected sepsis or trauma who require organ support.
✕Probably not a fit
Patients who are on anticoagulant therapy, not for full ICU support, or deemed to have an inevitable death within 24 hours may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on critically ill patients suffering from sepsis or trauma, aiming to identify those at risk of excessive blood clot formation using Viscoelastic Testing (VET) technology. The study will evaluate the effectiveness of new blood coagulation drugs and guide the use of blood-modifying treatments at the bedside. By understanding the mechanisms behind fibrinolysis resistance, the research seeks to personalize treatment approaches to improve patient outcomes in these high-risk populations.
Why it matters
Potential benefit: If successful, this study could lead to more effective management of blood coagulation disorders in critically ill patients, potentially reducing organ failure and improving survival rates.
How similar studies have gone: While previous clinical trials addressing coagulopathies in sepsis have faced challenges, the use of VET technology has shown promise in identifying fibrinolysis resistance, suggesting potential for success in this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Sepsis/Septic shock Inclusion Criteria: * Admission to ICU, needing at least one organ supportand principally for the management of clinically suspected Sepsis or Septic shock according to Spesis-3 criteria (including SARS-COV-2) * Expected to remain in ICU and survive beyond the day after tomorrow Sepsis Exclusion Criteria: * On oral anticoagulant/antiplatelet therapy * Not for full, active ICU support * Death is deemed inevitable within 24 hrs Trauma Inclusion Criteria: * Trauma is the principal diagnosis on ICU admission * Expected to remain in ICU and survive beyond the day after tomorrow * Receiving respiratory support at the time of ICU admission - high-flow nasal prongs, non-invasive or invasive ventilation * Already received, or considered at risk of needing a blood product transfusion within 24 hrs of injury Trauma Exclusion Criteria: * Nursing home resident * Unsurvivable head injury * Not for full, active ICU support * Death is deemed inevitable within 24 hrs
Where it's running
-
The Canberra hospital (ICU)
Canberra, Australian Capital Territory, Australia Recruiting -
Liverpool Hospital (ICU)
Liverpool, New South Wales, Australia Recruiting -
Macquarie University Hospital (ICU)
Macquarie, New South Wales, Australia Recruiting -
Royal North Shore Hospital (ICU)
St Leonards, New South Wales, Australia Recruiting
Study contacts
- Study coordinator: Anders Aneman, MD, PhD, EDIC, FCICM
- Email: anders.aneman@health.nsw.gov.au
- Phone: +61427915693
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.