[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557873":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":19,"responsibleParty":35,"collaborators":37,"id":40,"slug":7,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":7,"eligibilityCriteria":44,"healthyVolunteers":41,"sex":45,"minAge":7,"maxAge":7,"enrollmentInfo":46,"targetDuration":7,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":7,"overallStatus":55,"whyStopped":7,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},{"fullName":5,"class":6},"Diagast","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","Safety Test ABO and ABTest Card®","Pre transfusional control with the Safety Test ABO device (reference device) and the ABTest Card® device (comparator).",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Céline BOURIEZ","CONTACT","+33 (0) 3.20.96.53.86","regulatory@diagast.com",[20],{"facility":21,"status":7,"city":22,"state":7,"zip":7,"country":23,"cosmosGeoPoint":24,"geoPoint":29,"contacts":30},"CHU Montpellier","Montpellier","France",{"type":25,"coordinates":26},"Point",[27,28],3.87635,43.61093,{"lat":28,"lon":27},[31,33],{"name":32,"role":16,"phone":7,"phoneExt":7,"email":7},"Virginie TUNEZ",{"name":32,"role":34,"phone":7,"phoneExt":7,"email":7},"PRINCIPAL_INVESTIGATOR",{"type":36,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[38],{"name":39,"class":6},"Soladis","100557873",false,"NCT06543771","Clinical Performance Study of Safety Test ABO Device","Inclusion Criteria:\n\n* Age ≥ 18 years old for the category marked with \\*.\n* Undergo capillary blood sampling;\n* Belong to one of the clinical category:\n\n  * Patient in need of blood transfusion without any pathology known to have an impact on transfusion act\\*;\n  * Patient in need of blood transfusion suffering from congenital erythrocyte pathology (sickle cell anaemia, beta thalassemia)\\*\n  * Patient in need of blood transfusion suffering from haematology disease (eg. cancer), or undergoing haemodialysis\\*;\n  * Patient with cold agglutinin\\*;\n  * Premature patient with gestational age \\\u003C 37 weeks of newborn ≤27 days old in need of blood transfusion;\n  * Newborn eligible for Guthrie Test;\n  * Newborn eligible for glycemic test.\n* Have health care insurance;\n* Have given his\u002Fher written consent (or legal representative in case of newborn);\n\nExclusion Criteria:\n\n* Pregnant woman;\n* Person deprived of liberty;\n* Unconscious person;\n* Person under guardianship or trusteeship;\n* For neonatal clinical category: age ≥28 days and \\\u003C18 years old.","ALL",{"count":47,"type":48},100,"ESTIMATED","INTERVENTIONAL",[51],"NA","The study aims to confirm the performance equivalence of the in vitro diagnostic device Safety Test ABO with the ABTest Card device.",[54],"Transfusion Reaction","NOT_YET_RECRUITING","2024-08-06",{"date":58,"type":59},"2024-08-09","ACTUAL",{"date":61,"type":48},"2024-09",{"date":63,"type":48},"2025-01",{"name":5,"class":6},1]