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RECRUITING

NCT05540834

PHASE2

Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure

Sponsor: South West Sydney Local Health District

View on ClinicalTrials.gov

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.

Official title: A Phase 2 Safety, Dose-finding and Efficacy Study Evaluating Viscoelastic Testing (VET) Guided Tissue Plasminogen Activator (tPA) Treatment in Critically-ill Pro-thrombotic Acute Respiratory Failure

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-05-18

Completion Date

2026-12-01

Last Updated

2024-04-17

Healthy Volunteers

Conditions

Acute Respiratory Failure Hypercoagulability Fibrinolysis Shutdown

Interventions

DRUG

Alteplase

The enzyme tissue plasminogen activator that cleaves plasminogen to form plasmin.

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

Locations (1)

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

Liverpool, New South Wales, Australia