Using viscoelastic testing to guide tPA treatment for acute respiratory failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to improve treatment for patients experiencing acute respiratory failure (ARF) by utilizing viscoelastic testing (VET) to identify those at increased risk of thrombosis. The study focuses on both COVID and non-COVID related ARF, where patients often exhibit a hypercoagulable state and impaired fibrinolysis. By guiding the administration of tissue plasminogen activator (tPA) based on VET results, the trial seeks to personalize treatment to enhance efficacy and safety. The approach is designed to address the limitations of standard coagulation tests and provide a more accurate assessment of coagulation status in critically ill patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Acute respiratory failure of primary pulmonary infectious or extrapulmonary infectious aetiology with severity graded by the arterial oxygen partial pressure to inspired fraction of oxygen ratio (P/F) as per the Berlin definition: acute onset of hypoxemia with an arterial partial pressure of oxygen (PaO2) to inspired fraction of oxygen (FiO2) ratio of less than or equal to 300 mmHg with positive end expiratory pressure (PEEP) of 5 cm of water (H2O) or greater
2. Requiring admission to Intensive Care
3. Aged 18 - 75 years of age
4. Procoagulant profile on ClotPro (TradeMark) fibrinogen (FIB)-test +/- extrinsic coagulation pathway (EX)-test - above normal range for amplitude at 10 minutes (A10) and/or maximal clot firmness (MCF) at 30 minutes run time
5. Lysis Time on ClotPro tissue plasminogen activator (TPA)-test ClotPro equal to or greater than 365 seconds

Exclusion Criteria:

1. Platelet count \<150 x 109/L or a reduction in platelet count of 50% or more in the last 24 hours
2. Body weight \< 60 kg
3. Structural intracranial disease e.g. arterio-venous malformation or aneurysm
4. Previous intracranial haemorrhage
5. Ischaemic stroke within 3 months
6. Traumatic cardiopulmonary resuscitation
7. Hypoxaemia from traumatic lung injury
8. Active or recent bleeding
9. Recent surgery, trauma or invasive procedure
10. Systolic blood pressure (BP) \> 180 mm Hg
11. Diastolic BP \> 100 mm Hg
12. Pericarditis or pericardial fluid
13. Diabetic retinopathy
14. Currently menstruating
15. Pregnancy - (beta-human chorionic gonadotropin (HCG) to be performed if of child-bearing age)
16. Liver failure (known severe liver disease or an alanine aminotransferase or an aspartate aminotransferase level that is 5 times the upper limit of normal)
17. Kidney failure (estimated Glomerular Filtration Rate (eGFR =\<30 mL/hr or receiving renal replacement therapy)
18. Use of therapeutic anticoagulation or platelet antagonists
19. Not for active treatment
20. Unlikely to survive until the day after tomorrow

Where it's running

• Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District
  Liverpool, New South Wales, Australia Recruiting

Study contacts

• Principal investigator: Anders Aneman — Sydney WAHS
• Study coordinator: Anders Aneman
• Email: Anders.Aneman@health.nsw.gov.au
• Phone: +61 427915693

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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.