Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05540834

Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure

Led by South West Sydney Local Health District · Updated on 2024-04-17

70

Participants Needed

1

Research Sites

236 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Patients with coronavirus disease (COVID) and non-COVID acute respiratory failure (ARF) may be at an increased risk of thrombosis due to increased clot formation and decreased clot lysis. This two stage study aims to utilise bedside coagulation technology to detect patients at increased risk and guide tPA treatment to maximise efficacy and safety through a personalised approach.

CONDITIONS

Official Title

Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Acute respiratory failure with hypoxemia defined by PaO2/FiO2 ratio ≤ 300 mmHg and PEEP ≥ 5 cm H2O
  • Admission to intensive care
  • Age between 18 and 75 years
  • Procoagulant blood profile on ClotPro fibrinogen or extrinsic coagulation tests showing elevated amplitude or clot firmness
  • Lysis time on ClotPro tissue plasminogen activator test equal to or greater than 365 seconds
Not Eligible

You will not qualify if you...

  • Platelet count below 150 x 10^9/L or decrease of 50% or more in last 24 hours
  • Body weight less than 60 kg
  • Structural intracranial disease such as arteriovenous malformation or aneurysm
  • Previous intracranial hemorrhage
  • Ischemic stroke within past 3 months
  • Traumatic cardiopulmonary resuscitation
  • Hypoxemia caused by traumatic lung injury
  • Active or recent bleeding
  • Recent surgery, trauma, or invasive procedure
  • Systolic blood pressure above 180 mm Hg
  • Diastolic blood pressure above 100 mm Hg
  • Pericarditis or presence of pericardial fluid
  • Diabetic retinopathy
  • Currently menstruating
  • Pregnancy (beta-HCG test required if of child-bearing age)
  • Severe liver failure or liver enzyme levels 5 times above normal
  • Kidney failure with eGFR ≤ 30 mL/hr or receiving dialysis
  • Use of therapeutic anticoagulants or platelet blockers
  • Not receiving active treatment
  • Unlikely to survive beyond the next day

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District

Liverpool, New South Wales, Australia, 1871

Actively Recruiting

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Research Team

A

Anders Aneman

CONTACT

L

Lucy Coupland

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure | DecenTrialz