Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSouth West Sydney Local Health District
About this trial
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
Qualifiers
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
Requiring admission to Intensive Care
Aged 18 - 75 years of age
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
Disqualifiers
Platelet count <150 x 109/L or a reduction in platelet count of 50% or more in the last 24 hours
Body weight < 60 kg
Structural intracranial disease e.g. arterio-venous malformation or aneurysm
Previous intracranial haemorrhage
Trial design
Treatments tested in this trial
- Alteplase
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov