[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504975":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":28,"locations":39,"responsibleParty":55,"collaborators":10,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":10,"enrollmentInfo":67,"targetDuration":10,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":10,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Assistance Publique Hopitaux De Marseille","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with pulmonary embolism",null,"The presence of pulmonary embolism is determined from a CT scan realized between Day 5 and Day 28.",[13],"Other: Blood sample",{"label":15,"type":10,"description":16,"interventionNames":17},"Patients without pulmonary embolism","The absence of pulmonary embolism is determined from a CT scan realized between Day 5 and Day 28.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"Blood sample","Additional blood samples will be taken on a catheter, used for standard care.",[9,15],[24],{"name":25,"affiliation":26,"role":27},"François Cremieux","AP-HM","STUDY_DIRECTOR",[29,35],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Giovanni Bousquet, MD","CONTACT","0491964252","33","giovanni.bousquet@ap-hm.fr",{"name":36,"role":31,"phone":37,"phoneExt":33,"email":38},"Christophe Guervilly, MD","0491965842","christophe.guervilly@ap-hm.fr",[40],{"facility":41,"status":42,"city":43,"state":10,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Service Médecine intensive et réanimation","RECRUITING","Marseille","13015","France","FR",{"type":48,"coordinates":49},"Point",[50,51],5.38107,43.29695,{"lat":51,"lon":50},[54],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},{"type":56,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100504975","association-between-the-level-of-ev-tf-and-the-occurence-of-pulmonary-embolism-in-patients-with-ards-100504975",false,"NCT05855317","Association Between the Level of EV-TF and the Occurence of Pulmonary Embolism in Patients With ARDS","Association Between the Level of Extracellular Vesicle - Associated Tissue Factor and the Occurence of Pulmonary Embolism in Patients With Acute Respiratory Distress Syndrome","THROMBO-EVTF","Inclusion Criteria:\n\n* Patient 18 years of age or older,\n* Patient who has given his\u002Fher non-opposition to participate in this study, or alternatively, patient for whom a relative has given his\u002Fher non-opposition to participate in this study,\n* Patient admitted to intensive care for less than 24 hours,\n* Patient with ARDS according to the Berlin criteria,\n\n  * Hypoxemia with PaO2\u002FFiO2 ratio ≤ 300 on mechanical ventilation under PEEP ≥ 5 cmH2O,\n  * Bilateral alveolar-interstitial opacities on chest imaging (chest X-ray or CT),\n  * Exclusion of a cardiogenic cause on echocardiography,\n  * Acute or subacute onset within 7 days based on the clinical-radiological profile.\n\nExclusion Criteria:\n\n* Positive SARS-CoV-2 PCR in a pharyngeal or respiratory sample (cytobacteriological examination of sputum, bronchial aspiration or bronchoalveolar lavage) prior to admission to the intensive care unit,\n* Patient with a pathology affecting the coagulation process or endothelial function (hemophilia, von Willebrand disease, etc.),\n* Patient receiving curative anticoagulant treatment before admission to the intensive care unit,\n* Patient undergoing extracorporeal veno-venous respiratory assistance (ECMO-VV) before admission to the intensive care unit,\n* Patient undergoing extra-renal purification with systemic anticoagulation with heparin before admission to the intensive care unit,\n* Persons referred to in articles L. 1121-5 to L. 1121-8 of the Public Health Code (minor patients, adult patients under tutorship or guardianship, patients deprived of their liberty, pregnant or nursing women),\n* Moribund patients for whom the life expectancy is less than 24 hours according to the opinion of the investigating physician.","ALL","18 Years",{"count":68,"type":69},170,"ESTIMATED","OBSERVATIONAL","In this study, 120 patients with Acute Respiratory Distress Syndrome (ARDS) will be included on a two years-period in an intensive care unit (Assistance Publique des Hôpitaux de Marseille, France). Those patients will benefit from a blood test at inclusion in order to measure several coagulation biomarkers, including EV-TF. Subsequently, these patients will be treated according to the usual practices of the department, following recommendations. Patients who received an injected CT scan between Day 5 and Day 28 will be divided into two groups based on the presence or absence of a pulmonary embolism on imaging. The measured values of EV-TF levels and other studied biomarkers will be compared between these two groups in order to detect a possible association between them and the diagnosis of pulmonary embolism. It should be noted that patients receiving an injected CT-scan between Day 5 and Day 7 will be included in the main analysis while those receiving it between Day 8 and Day 28 will be included in the secondary analysis. Others will be excluded from any analysis. At the same time, several collections of clinical data will be carried out: on Day 1, Day 7, Day 28, and on the day of the CT scan if it is performed at another time.",[73],"Acute Respiratory Distress Syndrome","2026-02-02",{"date":76,"type":77},"2026-02-04","ACTUAL",{"date":79,"type":77},"2023-10-31",{"date":81,"type":69},"2027-10-30",{"name":5,"class":6},1]