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Recruiting Phase 2 NCT05540834

Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure

Trial Parameters

Condition Acute Respiratory Failure
Sponsor South West Sydney Local Health District
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 70
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2022-05-18
Completion 2026-05-01
Interventions
Alteplase

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

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