Clinical Trials in Australia / NCT05540834
Recruiting
Phase 2
Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure
NCT05540834 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
Acute Respiratory FailureHypercoagulabilityFibrinolysis Shutdown
Investigational drug(s) / intervention(s)
Alteplase: The enzyme tissue plasminogen activator that cleaves plasminogen to form plasmin.
Study summary
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.
Eligibility
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
Primary outcome measure(s)
- Change in clot lysis time on viscoelastic testing from baseline and up to 72 hours — From start to end of alteplase infusion + 1 and up to 72 hours later/ equivalent timeframe in controls
The impact of alteplase administration on the clot lysis time (in seconds) measured by the TPA-test using the ClotPro at the bedside
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District | Liverpool | New South Wales | Recruiting |
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Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05540834 on ClinicalTrials.gov ↗ ← All trials in Australia