RecruitingNCT06680180

Fibrinolysis Resistance in Infection and Trauma


Sponsor

Anders Aneman

Enrollment

150 participants

Start Date

Jun 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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
  • 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

Exclusion Criteria7

  • On oral anticoagulant/antiplatelet therapy
  • Not for full, active ICU support
  • Death is deemed inevitable within 24 hrs
  • Nursing home resident
  • Unsurvivable head injury
  • Not for full, active ICU support
  • Death is deemed inevitable within 24 hrs

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Interventions

DIAGNOSTIC_TESTViscoelastometric 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

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NCT06680180


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