Assessing blood clotting issues in patients with sepsis and trauma
Fibrinolysis Resistance in Infection and Trauma
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | South West Sydney Local Health District Academic / other |
| Locations | 4 sites (Canberra, Australian Capital Territory and 3 other locations) |
| Trial ID | NCT06680180 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include critically ill patients admitted to the ICU with clinically suspected sepsis or trauma who require organ support.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Canberra, Australian Capital Territory and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.