NCT05540834 Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure
| NCT ID | NCT05540834 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | South West Sydney Local Health District |
| Condition | Acute Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2022-05-18 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 70 participants in total. It began in 2022-05-18 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Anders Aneman
PRINCIPAL INVESTIGATOR
Sydney WAHS
Frequently Asked Questions
Who can join the NCT05540834 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Acute Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05540834 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05540834 currently recruiting?
Yes, NCT05540834 is actively recruiting participants. Contact the research team at Anders.Aneman@health.nsw.gov.au for enrollment information.
Where is the NCT05540834 trial being conducted?
This trial is being conducted at Liverpool, Australia.
Who is sponsoring the NCT05540834 clinical trial?
NCT05540834 is sponsored by South West Sydney Local Health District. The principal investigator is Anders Aneman at Sydney WAHS. The trial plans to enroll 70 participants.