[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multiple-trauma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multiple-trauma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100314024","phase-3-inhaled-dornase-alpha-to-reduce-respiratory-failure-after-severe-trauma-100314024",false,"NCT03368092","Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma","A Prospective, Randomized Multicenter, Double Blind Clinical Trial Comparing Inhaled Dornase Alfa and Its Placebo to Reduce the Incidence of Moderate to Severe ARDS in Ventilated Trauma Patients in the Intensive Care Unit","TRAUMADORNASE","Inclusion Criteria:\n\n* Adult (\\>18) patient of either sex affiliated to the National Health Service\n\n  * Severe trauma patient (either blunt or penetrating), Injury Severity Score \\> 15\n  * Under mechanical ventilation for an expected duration \\> 48h\n  * Admitted in the ICU\n  * Signed informed consent from the patient's relative\n  * Patient equipped with an indwelling arterial catheter\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding\n\n  * Opposition from the patient or his\u002Fher relatives\n  * Protected major (Guardianship)\n  * Contraindication to the use of dornase alfa\n  * Known intolerance to dornase alfa","ALL","18 Years",{"count":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Severe hypoxemia following trauma may happen in many circumstances (aspiration, ventilation-associated pneumonia, lung contusion...), most of which are not exclusively associated with a direct injury to the lungs. Severe trauma and associated musculoskeletal injuries result in the acute release of Damage-Associated Molecular Patterns (DAMPs) in plasma, many of which are made of nucleic acids. DAMPs then bind leukocytes and trigger NETosis (Neutrophil Extracellular Traps), the release of nuclear material coated with proteolytic enzymes, which ultimately promotes remote lung injury and acute respiratory distress syndrome (ARDS).\n\nConsidering that many DAMPs and all NETs are made of nucleic acids, we hypothesize that dornase alfa, a commercially available recombinant desoxyribonuclease (DNAse) could reduce DAMPs and NETs-induced lung injury in severe trauma patients under mechanical ventilation in the intensive care unit (ICU).\n\nThe primary objective is to demonstrate a reduction in the incidence of moderate to severe ARDS in severe trauma patients during the first seven ICU days from 45% to 30% by providing aerosolized dornase alfa once during the first two consecutive ICU days and compared to equivalent provision of placebo (NaCl 0,9%).\n\nThe secondary objectives are to demonstrate, by using aerosolized dornase alfa compared to placebo:\n\n* an improvement in static lung compliance\n* a reduction in mechanical ventilation duration \u002F an increase in ventilation-free ICU days\n* a reduction in the length of ICU stay\n* a reduction in the hospital length of stay\n* a reduction in multi-organ failure\n* a reduction in ventilator-associated pneumonia (VAP)\n* a reduction in mortality at day 28",[27,28],"Multiple Trauma","Respiratory Distress Syndrome, Adult",[30,31,32,33,34],"severe trauma","acute respiratory distress syndrome","damage-associated molecular patterns","neutrophil extracellular traps","dornase alfa","RECRUITING","2025-08-04",{"date":38,"type":39},"2025-08-08","ACTUAL",{"date":41,"type":39},"2019-03-04",{"date":43,"type":21},"2027-12-01",{"name":45,"class":46},"University Hospital, Strasbourg, France","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":69,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100407660","phase-3-erythropoietin-alfa-to-prevent-mortality-and-reduce-severe-disability-in-critically-ill-trauma-patients-100407660","NCT04588311","ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients","A Randomised, Double-blind, Placebo-controlled Trial of Erythropoietin Alfa Versus Placebo in Mechanically Ventilated Critically Ill Patients Following Traumatic Injury","EPO-TRAUMA","Inclusion Criteria: Patients with trauma admitted to the ICU who:\n\n* Are ≥ 18 to ≤ 75 years of age\n* Are \\\u003C 24 hours since primary traumatic injury\n* Are invasively mechanically ventilated\n* Are expected to stay in the ICU ≥ 48 hours\n* Have a haemoglobin not exceeding the upper limit of the applicable normal (ULN) reference range in clinical use at the treating institution\n* Have informed consent from a legal surrogate according to local law\n\nExclusion Criteria: Patients will be excluded from the study if any of the following criteria apply:\n\n* GCS = 3 and fixed dilated pupils\n* Recent history of DVT, PE or other thromboembolic event (within previous 12 months or receiving concomitant anticoagulant treatment for this indication)\n* A chronic hypercoagulable disorder, including known malignancy\n* Treatment with EPO in the last 30 days\n* First dose of study drug unable to be given within 24 hours of primary injury\n* Pregnancy or lactation or 3 months postpartum\n* Expected to die imminently (\\\u003C 24 hours)\n* Known sensitivity to mammalian cell derived products\n* Known contraindication to epoetin alfa\n* End stage renal failure (receives chronic dialysis)\n* Severe pre-existing physical or mental disability or severe co-morbidity that may interfere with the assessment of outcome\n* The treating physician believes it is not in the best interest of the patient to be randomised to this trial","75 Years",{"count":58,"type":21},2500,[24],"The EPO-TRAUMA study is a prospective, multi-centre, double-blind, phase III, randomised controlled trial evaluating the efficacy of epoetin alfa compared to placebo in reducing mortality and severe disability at six months in critically ill trauma patients.\n\n2500 mechanically ventilated ICU patients admitted with a primary trauma diagnosis presenting to the ICU will be recruited into the study from participating study centres in Australia, New Zealand, Europe, and Saudi Arabia.",[62,63,64,65,66,67,68,27],"Trauma","Traumatic Injury","Traumatic Brain Injury","Wounds and Injuries","Penetrating Injury","Blunt Injury","Major Trauma",[70,62,71,72,73,74,75],"Intensive Care Unit","Major trauma","Traumatic injury","EPO","Erythropoietin","Epoetin alfa","2025-07-14",{"date":78,"type":39},"2025-07-16",{"date":80,"type":39},"2020-11-09",{"date":82,"type":21},"2027-08-31",{"name":84,"class":46},"Australian and New Zealand Intensive Care Research Centre",41]