[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641590":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":10,"responsibleParty":21,"collaborators":10,"id":23,"slug":24,"hasResults":25,"nctId":26,"briefTitle":27,"officialTitle":28,"acronym":29,"eligibilityCriteria":30,"healthyVolunteers":25,"sex":31,"minAge":10,"maxAge":10,"enrollmentInfo":32,"targetDuration":10,"studyType":35,"phases":10,"briefSummary":36,"conditions":37,"keywords":40,"overallStatus":47,"whyStopped":10,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":10},{"fullName":5,"class":6},"Medical University of Graz","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Fibrinogen conentrate",null,"Human fibrinogen concentrate samples stored under routine operating conditions in a ground-based EMS ambulance and analyzed longitudinally during the study period.",{"label":13,"type":10,"description":14,"interventionNames":10},"Octaplas LG AB","Lyophilized human plasma samples stored under routine operating conditions in a ground-based EMS ambulance and analyzed longitudinally during the study period.",[16],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Maximilian Niederer, MD","CONTACT","0316385081237","maximilian.niederer@medunigraz.at",{"type":22,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100641590","stability-of-blood-clotting-products-stored-in-emergency-ambulances-under-real-world-conditions-100641590",false,"NCT07646964","Stability of Blood Clotting Products Stored in Emergency Ambulances Under Real-World Conditions","Stability of Human Fibrinogen (Fibryga) and Lyophilized Human Plasma (Octaplas LG AB) Under Real-World Prehospital Emergency Medical Service Storage Conditions: A Prospective Observational Study","STABLE-EMS","Inclusion Criteria:\n\n* Fibryga samples stored in the participating ground-based EMS ambulance.\n* Octaplas LG AB samples stored in the participating ground-based EMS ambulance.\n* Samples available for laboratory analysis at the predefined study time points.\n* Samples exposed to routine operational storage conditions during the study period.\n\nExclusion Criteria:\n\n* Samples with damaged packaging.\n* Samples with incomplete storage documentation.\n* Samples accidentally removed from the designated storage system during the observation period.\n* Samples unavailable for laboratory analysis.\n* Samples exposed to conditions not representative of routine EMS operation.","ALL",{"count":33,"type":34},2,"ESTIMATED","OBSERVATIONAL","Emergency medical service (EMS) vehicles are exposed to a wide range of environmental conditions, including high temperatures during summer months. These conditions may affect the stability and quality of medications and blood products carried for emergency treatment.\n\nThis observational study aims to evaluate the stability of human fibrinogen concentrates and human plasma proteins (Octaplas) when stored under routine operating conditions in a ground-based EMS ambulance in Graz, Austria. Drug samples will be analyzed monthly over a four-month period and compared with reference samples stored under recommended conditions. In addition, temperature inside the storage containers and the vehicle will be continuously monitored.\n\nThe study will assess whether prolonged exposure to real-world prehospital storage conditions affects product stability and whether any changes are associated with environmental factors. The findings may help determine whether current storage practices in EMS vehicles are adequate for maintaining the quality of these blood coagulation products.",[38,39],"Exanguination","Trauma Coagulopathy",[41,42,43,44,45,46],"Prehospital Care","Drug Storage","Temperature Monitoring","Fibrinogen Concentrate","Lyophilized Plasma","Coagulation Products","NOT_YET_RECRUITING","2026-06-15",{"date":50,"type":51},"2026-06-17","ACTUAL",{"date":53,"type":34},"2026-07-01",{"date":55,"type":34},"2026-11-30",{"name":5,"class":6}]