Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure

Launched by SOUTH WEST SYDNEY LOCAL HEALTH DISTRICT · Sep 12, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat patients who are experiencing acute respiratory failure, which can happen due to infections like COVID-19 or other serious lung issues. The study focuses on using a special test to assess blood clotting in patients, helping doctors determine who might benefit from a medication called tissue plasminogen activator (tPA). This treatment could help break down clots that are making it difficult for patients to breathe. The goal is to tailor the treatment to each patient’s needs for better safety and effectiveness.

To be eligible for the trial, participants need to be between 18 and 75 years old and must be in a critical state that requires admission to intensive care. They should also have specific blood clotting profiles that indicate a risk of clot formation or breakdown. Participants will be closely monitored throughout the trial and will receive personalized treatment based on their individual test results. It's important to know that there are certain health conditions that would exclude someone from participating, such as recent surgery, active bleeding, or severe liver or kidney problems. This study is currently recruiting participants who meet these criteria.

Gender

ALL

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