A Phase 2 Safety, Dose-finding and Efficacy Study Evaluating Viscoelastic Testing (VET) Guided Tissue Plasminogen Activator (tPA) Treatment in Critically-ill Pro-thrombotic Acute Respiratory Failure (VETtiPAT-ARF)

  • End date
    Jul 17, 2024
  • participants needed
  • sponsor
    South West Sydney Local Health District
Updated on 17 October 2022


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.


Acute respiratory failure (ARF) due to COVID is associated with an increased risk of thrombosis causing death. Therapeutic heparin administration was not beneficial in the critically ill.

In non-COVID ARF patients, the presence of multiple pulmonary vessel filling defects associated with the severity of disease and patient outcome, and resolved following the administration of the fibrinolytics, streptokinase and urokinase. An early phase I study reported improved oxygenation in patients with severe ARF following administration of plasminogen activators. The rationale for fibrinolytics in ARF has been published previously and is supported by meta-analysis of preclinical studies.

In both non-COVID and COVID associated ARF, defective fibrinolysis has been demonstrated. Standard coagulation tests cannot identify a hypercoagulable state nor assess fibrinolysis whereas viscoelastic testing (VET), a rapid, point-of-care device commonly used in Intensive Care, is able to detect these disorders. Numerous studies have demonstrated that VET is sufficiently sensitive to detect the coagulopathies associated with ARF, with several parameters associating with disease severity.

The VETtiPAT ARF trial uses VET to identify ARF patients with a procoagulant and hypofibrinolytic phenotype, then to guide tPA (Alteplase) administration thus maximising efficacy and safety through a personalised precision medicine approach.

Condition Acute Respiratory Failure, Hypercoagulability, Fibrinolysis Shutdown
Treatment Alteplase
Clinical Study IdentifierNCT05540834
SponsorSouth West Sydney Local Health District
Last Modified on17 October 2022


Yes No Not Sure

Inclusion 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 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
Lysis Time on ClotPro tissue plasminogen activator (TPA)-test ClotPro equal to or greater than 365 seconds

Exclusion Criteria

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
Clear my responses

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