[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568358":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":34,"responsibleParty":95,"collaborators":99,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":116,"sex":117,"minAge":118,"maxAge":10,"enrollmentInfo":119,"targetDuration":122,"studyType":123,"phases":10,"briefSummary":124,"conditions":125,"keywords":128,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"South West Sydney Local Health District","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sepsis\u002FSeptic shock",null,"According to Sepsis-3 definitions (including SARS CoV-2 as pathogen); expected to remain in ICU and survive beyond the day after tomorrow and for full, active ICU treatment; arterial and secure venous access established or imminent as part of standard care; not on oral anticoagulant\u002Fantiplatelet therapy.",[13],"Diagnostic Test: Viscoelastometric assessment of fibrinolysis",{"label":15,"type":10,"description":16,"interventionNames":17},"Severe Trauma","Admitted via the Emergency Department resuscitation bay requiring trauma team response; deemed at risk of significant blood loss and where transfusion of blood products i considered in the ED during the acute phase of the resuscitation by a senior clinician; expected to remain in ICH and survive beyond the day after tomorrow and for full, active ICU treatment; Not on oral anticoagulant\u002Fantiplatelet therapy. A clinical based inclusion approach is the most pragmatic means of patient selection and can be objectively supported by routine blood tests demonstrating poor oxygen supply to the organs. Exclusion criteria: unsurvivable head injury.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","Viscoelastometric assessment of fibrinolysis","Viscoelastometric assessment of whole blood fibrinolysis using supplemental tissue plasminogen activator (tPA) and other agents ex vivo to influence fibrinolysis capacity.",[9,15],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Anders Aneman, MD, PhD, EDIC, FCICM","CONTACT","+61427915693","anders.aneman@health.nsw.gov.au",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},"Lucy Coupland, Nurs Cert, BSci (hons), PhD","+61419723330","lucy.coupland@health.nsw.gov.au",[35,57,74,81],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"The Canberra hospital (ICU)","RECRUITING","Canberra","Australian Capital Territory","2605","Australia","AU",{"type":44,"coordinates":45},"Point",[46,47],149.12807,-35.28346,{"lat":47,"lon":46},[50,54],{"name":51,"role":27,"phone":52,"phoneExt":10,"email":53},"Philip Crispin, MBBS(Hons), FRACP, FRCPA","+ 61251240000","philip.crispin@act.gov.au",{"name":55,"role":27,"phone":52,"phoneExt":10,"email":56},"Sean W Chan","seanweng.chan@act.gov.au",{"facility":58,"status":37,"city":59,"state":60,"zip":61,"country":41,"countryCode":42,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Liverpool Hospital (ICU)","Liverpool","New South Wales","2170",{"type":44,"coordinates":63},[64,65],150.92588,-33.91938,{"lat":65,"lon":64},[68,70],{"name":31,"role":27,"phone":69,"phoneExt":10,"email":33},"+ 61419723330",{"name":71,"role":27,"phone":72,"phoneExt":10,"email":73},"Eurwin Suryana, BMedSci (hons), PhD","+ 61415148742","eurwin.suryana@health.nsw.gov.au",{"facility":75,"status":37,"city":76,"state":60,"zip":77,"country":41,"countryCode":42,"cosmosGeoPoint":10,"geoPoint":10,"contacts":78},"Macquarie University Hospital (ICU)","Macquarie","2109",[79],{"name":26,"role":27,"phone":80,"phoneExt":10,"email":29},"+ 61427915693",{"facility":82,"status":37,"city":83,"state":60,"zip":84,"country":41,"countryCode":42,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Royal North Shore Hospital (ICU)","St Leonards","2065",{"type":44,"coordinates":86},[87,88],151.19836,-33.82344,{"lat":88,"lon":87},[91],{"name":92,"role":27,"phone":93,"phoneExt":10,"email":94},"Pierre Janin","+ 61299267111","pierre.janin@health.nsw.gov.au",{"type":96,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Anders Aneman","Conjoint Professor",[100,103,105,107],{"name":101,"class":102},"Liverpool Hospital, South Western Sydney Local Health District","UNKNOWN",{"name":104,"class":6},"The Canberra Hospital",{"name":106,"class":6},"Royal North Shore Hospital",{"name":108,"class":6},"Macquarie University, Australia","100568358","fibrinolysis-resistance-in-infection-and-trauma-100568358",false,"NCT06680180","Fibrinolysis Resistance in Infection and Trauma","FORTITUDE","Sepsis\u002FSeptic shock Inclusion Criteria:\n\n* Admission to ICU, needing at least one organ supportand principally for the management of clinically suspected Sepsis or Septic shock according to Spesis-3 criteria (including SARS-COV-2)\n* Expected to remain in ICU and survive beyond the day after tomorrow\n\nSepsis Exclusion Criteria:\n\n* On oral anticoagulant\u002Fantiplatelet therapy\n* Not for full, active ICU support\n* Death is deemed inevitable within 24 hrs\n\nTrauma Inclusion Criteria:\n\n* Trauma is the principal diagnosis on ICU admission\n* Expected to remain in ICU and survive beyond the day after tomorrow\n* Receiving respiratory support at the time of ICU admission - high-flow nasal prongs, non-invasive or invasive ventilation\n* Already received, or considered at risk of needing a blood product transfusion within 24 hrs of injury\n\nTrauma Exclusion Criteria:\n\n* Nursing home resident\n* Unsurvivable head injury\n* Not for full, active ICU support\n* Death is deemed inevitable within 24 hrs",true,"ALL","18 Years",{"count":120,"type":121},150,"ESTIMATED","15 Days","OBSERVATIONAL","Blood coagulation disorders are often seen in critically ill patients e.g. with severe infection or following extensive injury, that can lead to life threatening events as a result of excessive blood clot formation leading to organ failure. This study aims to use Viscoelastic Testing (VET) technology to detect patients at risk of excessive blood blot formation at the bedside, test new blood coagulation drugs, and guide life-saving use of blood modifying treatments.",[126,127],"Sepsis and Septic Shock","Trauma",[129,130,127,131,132,133,134],"Viscoelastic testing (VET)","Sepsis","Fibrinolytic Agents","Fibrin Modulating Agents","Tissue Plasminogen Activator","Plasminogen","2024-11-06",{"date":137,"type":138},"2024-11-08","ACTUAL",{"date":140,"type":138},"2024-06-01",{"date":142,"type":121},"2026-06-01",{"name":97,"class":6},4]