RECRUITINGOBSERVATIONAL
Fibrinolysis Resistance in Infection and Trauma
About This Trial
Blood coagulation disorders are often seen in critically ill patients e.g. with severe infection or following extensive injury, that can lead to life threatening events as a result of excessive blood clot formation leading to organ failure. This study aims to use Viscoelastic Testing (VET) technology to detect patients at risk of excessive blood blot formation at the bedside, test new blood coagulation drugs, and guide life-saving use of blood modifying treatments.
Who May Be Eligible (Plain English)
Sepsis/Septic shock Who May Qualify:
- 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 Who Should NOT Join This Trial:
- On oral anticoagulant/antiplatelet therapy
- Not for full, active ICU support
- Death is deemed inevitable within 24 hrs
Trauma Who May Qualify:
- 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 Who Should NOT Join This Trial:
- Nursing home resident
- Unsurvivable head injury
- Not for full, active ICU support
- Death is deemed inevitable within 24 hrs
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DIAGNOSTIC_TEST
Viscoelastometric assessment of fibrinolysis
Viscoelastometric assessment of whole blood fibrinolysis using supplemental tissue plasminogen activator (tPA) and other agents ex vivo to influence fibrinolysis capacity.
Locations (4)
The Canberra hospital (ICU)
Canberra, Australian Capital Territory, Australia
Liverpool Hospital (ICU)
Liverpool, New South Wales, Australia
Macquarie University Hospital (ICU)
Macquarie, New South Wales, Australia
Royal North Shore Hospital (ICU)
St Leonards, New South Wales, Australia