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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Alteplase
DrugThe enzyme tissue plasminogen activator that cleaves plasminogen to form plasmin.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: VET guided tPA administration + standard careExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in clot lysis time on viscoelastic testing from baseline and up to 72 hours
The impact of alteplase administration on the clot lysis time (in seconds) measured by the TPA-test using the ClotPro at the bedside
Time frame
From start to end of alteplase infusion + 1 and up to 72 hours later/ equivalent timeframe in controlsSecondary outcomes
1
Change in VET coagulation parameters from baseline and up to 72 hours
The impact of alteplase administration on clot formation related to fibrinogen and the extrinsic pathway (maximum clot firmness (MCF) / amplitude at 10 minutes (A10) in millimeters) measured by the FIB-test and EX-test using the ClotPro at the bedside
Time frame
From start to end of alteplase infusion + 1 and up to 72 hours later/ equivalent timeframe in controls2
Changes in oxygenation
Arterial partial pressure of oxygen to inspired fraction of oxygen (P/F) ratio
Time frame
From start to end of alteplase infusion/ equivalent timeframe in controls3
Rate of participants with bleeding events
Any bleeding events Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater
Time frame
From study entry to Day 54
Rate of thromboembolic events
Any thromboembolic event
Time frame
From study entry to Day 30 or hospital discharge, whichever occurs firstSponsors and contacts
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Source ClinicalTrials.gov