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New treatment option for Acute Respiratory Failure
Official title Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure
ClinicalTrials.gov ID: NCT05540834
What this study is testing
What is Alteplase?
Alteplase is an investigational medicine, being studied as a potential treatment for acute respiratory failure.
Also referred to as Tissue plasminogen activator, tPA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Acute respiratory failure of primary pulmonary infectious or extrapulmonary infectious aetiology with severity graded by the arterial oxygen partial...
- 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...
- Lysis Time on ClotPro tissue plasminogen activator (TPA)-test ClotPro equal to or greater than 365 seconds
You likely can't join if
- 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
- Ischaemic stroke within 3 months
- Traumatic cardiopulmonary resuscitation
See the full eligibility criteria
- 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...
- 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...
- Lysis Time on ClotPro tissue plasminogen activator (TPA)-test ClotPro equal to or greater than 365 seconds
- 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
- Ischaemic stroke within 3 months
- Traumatic cardiopulmonary resuscitation
- Hypoxaemia from traumatic lung injury
- Active or recent bleeding
- Recent surgery, trauma or invasive procedure
- Systolic blood pressure (BP) \> 180 mm Hg
- Diastolic BP \> 100 mm Hg
- Pericarditis or pericardial fluid
- Diabetic retinopathy
- Currently menstruating
- Pregnancy - (beta-human chorionic gonadotropin (HCG) to be performed if of child-bearing age)
- Liver failure (known severe liver disease or an alanine aminotransferase or an aspartate aminotransferase level that is 5 times the upper limit of normal)
- Kidney failure (estimated Glomerular Filtration Rate (eGFR =\<30 mL/hr or receiving renal replacement therapy)
- Use of therapeutic anticoagulation or platelet antagonists
- Not for active treatment
- Unlikely to survive until the day after tomorrow
The study team makes the final eligibility decision.
Where it's taking place
- Liverpool, New South Wales, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Liverpool, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.