[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480811":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":64,"collaborators":18,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":18,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":18,"overallStatus":47,"whyStopped":18,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"South West Sydney Local Health District","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VET guided tPA administration + standard care","EXPERIMENTAL","Actilyse (tPA) will be administered as a 2-hour bolus then low dose infusion over 24 hours (safety and dose-finding stage) and 72 hours (randomised stage). Regular monitoring of the coagulation status and lysis time using VET will enable increases or decreases\u002Fcessation of the dose. Prophylactic low molecular weight heparin will continue throughout.",[13],"Drug: Alteplase",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard care","NO_INTERVENTION","Patients will receive standard care for their condition including prophylactic low molecular weight heparin. Coagulation status and lysis time monitoring with VET will occur at the same times as the experimental arm.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Alteplase","The enzyme tissue plasminogen activator that cleaves plasminogen to form plasmin.",[9],[26,27,28,29],"Tissue plasminogen activator","tPA","Actilyse","Activase",[31],{"name":32,"affiliation":33,"role":34},"Anders Aneman","Sydney WAHS","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":18,"email":39},"CONTACT","+61 427915693","Anders.Aneman@health.nsw.gov.au",{"name":41,"role":37,"phone":42,"phoneExt":18,"email":43},"Lucy Coupland","+61 419723330","l.coupland@unsw.edu.au",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District","RECRUITING","Liverpool","New South Wales","1871","Australia","AU",{"type":54,"coordinates":55},"Point",[56,57],150.92588,-33.91938,{"lat":57,"lon":56},[60],{"name":61,"role":37,"phone":62,"phoneExt":18,"email":63},"Anders Aneman, MD, PhD","+61 2 8738 3400","anders.aneman@swsahs.nsw.gov.au",{"type":34,"investigatorFullName":32,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Professor","100480811","phase-2-viscoelastic-testing-guided-tissue-plasminogen-activator-treatment-in-acute-respiratory-failure-100480811",false,"NCT05540834","Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure","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","Inclusion Criteria:\n\n1. 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\u002FF) 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\n2. Requiring admission to Intensive Care\n3. Aged 18 - 75 years of age\n4. Procoagulant profile on ClotPro (TradeMark) fibrinogen (FIB)-test +\u002F- extrinsic coagulation pathway (EX)-test - above normal range for amplitude at 10 minutes (A10) and\u002For maximal clot firmness (MCF) at 30 minutes run time\n5. Lysis Time on ClotPro tissue plasminogen activator (TPA)-test ClotPro equal to or greater than 365 seconds\n\nExclusion Criteria:\n\n1. Platelet count \\\u003C150 x 109\u002FL or a reduction in platelet count of 50% or more in the last 24 hours\n2. Body weight \\\u003C 60 kg\n3. Structural intracranial disease e.g. arterio-venous malformation or aneurysm\n4. Previous intracranial haemorrhage\n5. Ischaemic stroke within 3 months\n6. Traumatic cardiopulmonary resuscitation\n7. Hypoxaemia from traumatic lung injury\n8. Active or recent bleeding\n9. Recent surgery, trauma or invasive procedure\n10. Systolic blood pressure (BP) \\> 180 mm Hg\n11. Diastolic BP \\> 100 mm Hg\n12. Pericarditis or pericardial fluid\n13. Diabetic retinopathy\n14. Currently menstruating\n15. Pregnancy - (beta-human chorionic gonadotropin (HCG) to be performed if of child-bearing age)\n16. Liver failure (known severe liver disease or an alanine aminotransferase or an aspartate aminotransferase level that is 5 times the upper limit of normal)\n17. Kidney failure (estimated Glomerular Filtration Rate (eGFR =\\\u003C30 mL\u002Fhr or receiving renal replacement therapy)\n18. Use of therapeutic anticoagulation or platelet antagonists\n19. Not for active treatment\n20. Unlikely to survive until the day after tomorrow","ALL","18 Years","75 Years",{"count":78,"type":79},70,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","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.",[85,86,87],"Acute Respiratory Failure","Hypercoagulability","Fibrinolysis Shutdown","2024-04-15",{"date":90,"type":91},"2024-04-17","ACTUAL",{"date":93,"type":91},"2022-05-18",{"date":95,"type":79},"2026-12-01",{"name":5,"class":6},1]