[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619474":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":46,"collaborators":48,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":10,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Radiometer Medical ApS","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adults, 18 years of age or older, that have been admitted to hospital and undergo blood collection",null,"Adults, 18 years of age or older, that have been admitted to the hospital and undergo blood collection as part of their standard care will be eligible for participation. Many of these patients are admitted to the Intensive Care Unit (ICU) with acute injury or critical illness and are temporarily unconscious or sedated at the time of admission or during recovery in the intermediate care unit and post-anesthesia care unit due to their medical condition and required treatment (e.g., mechanical ventilation or sedation) and have an A- and or a V-line established for routine sample collection without additional burden as part of their standard care.",[13],"Diagnostic Test: The purpose of this study is to investigate the performance of the hemolysis detection function on the ABL90 FLEX PLUS HEM using arterial or venous whole blood",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","The purpose of this study is to investigate the performance of the hemolysis detection function on the ABL90 FLEX PLUS HEM using arterial or venous whole blood","The hemolysis detection function is a newly developed sample quality feature on the ABL90 FLEX PLUS HEM intended to detect hemolyzed samples and to improve the reliability of the results provided by blood gas analyzer.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Vadim Fedulov","CONTACT","+4526311594","vadim.fedulov@radiometer.dk",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Bispebjerg Hospital","RECRUITING","Copenhagen","NV","2400","Denmark","DK",{"type":36,"coordinates":37},"Point",[38,39],12.56553,55.67594,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":44,"phoneExt":10,"email":45},"Theis Itenov, MD, PhD","+45 51 34 19 45","theis.skovsgaard.itenov@regionh.dk",{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[49],{"name":28,"class":50},"OTHER","100619474","feasibility-performance-study-of-abl90-flex-plus-hem-100619474",false,"NCT07345091","Feasibility Performance Study of ABL90 FLEX PLUS HEM","Feasibility Performance Study Protocol for ABL90 FLEX PLUS HEM","ABL90FLEXHEM","Inclusion Criteria:\n\n* Subject must be 18 years of age or older\n* Informed consent is obtained:\n\n  * Directly from the subject, if they are competent and able to understand the provided information and voluntarily agree to participate, or\n  * If the subject is temporarily incapacitated and unable to provide informed consent at the time of sample collection, written informed consent will be obtained from the subject's legally designated representative (LDR). when the subject regains capacity after enrollment, they will be informed of study inclusion and given the opportunity to withdraw consent.\n* Subject evaluated as suitable according to the protocol and for the study by the principal investigator or designee.\n\nExclusion Criteria:\n\n* Subject where sample collection is evaluated by PI or designee to impose unnecessary risk.\n* Subject with an invalid written informed consent or who has withdrawn consent.\n* Subject with known pregnancy or who is breastfeeding.","ALL","18 Years",{"count":62,"type":63},95,"ESTIMATED","OBSERVATIONAL","This feasibility performance study evaluates the ABL90 FLEX PLUS HEM device for its analytical performance in a clinical setting. The study aims to evaluate the performance of the hemolysis detection feature.",[67],"Hemolysis",[69,70,71,72],"IVDR","Blood Gas Analyser","In vitro diagnostic","hemolysis detection","2026-01-07",{"date":75,"type":76},"2026-01-15","ACTUAL",{"date":78,"type":76},"2025-08-04",{"date":80,"type":63},"2026-06-10",{"name":5,"class":6},1]