Clinical trial Recruiting at 4 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment150 (estimated)
SponsorSouth West Sydney Local Health District
Academic / other
Locations4 sites (Canberra, Australian Capital Territory and 3 other locations)
StatusRecruiting
StartedJune 1, 2024
Main results expectedDecember 31, 2025
Study endsJune 1, 2026
Registry record updatedNovember 8, 2024
Trial IDNCT06680180 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.