The study of VET tPA treatment in acute respiratory failure

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The company South West Sydney Local Health District is commencing recruitment for the clinical trial of the Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure. The trial officially began in May 2022 and is planned to complete in July 2024.

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.

The conditions are acute respiratory failure, hypercoagulability, fibrinolysis shutdown. Patients that can be enrolled have 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), requiring admission to Intensive Care, 18 - 75 years of age, with procoagulant profile on ClotPro (TradeMark) fibrinogen (FIB)-test +/- external coagulation pathway (EX)-test - above normal range for amplitude at 10 minutes (A10) and/or maximal clot firmness (MCF) at 30 minutes run time Lysis Time on ClotPro tissue plasminogen activator (TPA)-test ClotPro equal to or greater than 365 seconds. Further details and criteria may be found here: https://ichgcp.net/clinical-trials-registry/NCT05540834.

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