[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547249":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":41,"responsibleParty":59,"collaborators":61,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":11,"enrollmentInfo":76,"targetDuration":11,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":11,"overallStatus":44,"whyStopped":11,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients undergoing cardiac surgery using the conventional cell saver device","ACTIVE_COMPARATOR",null,[13],"Device: Autologous blood cell salvage with in-house device",{"label":15,"type":16,"description":11,"interventionNames":17},"Patients undergoing cardiac surgery using the cell saver device","EXPERIMENTAL",[18],"Device: Autologous cell salvage with i-Sep SAME device",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","Autologous blood cell salvage with in-house device","In addition to standard procedures in this patient population, study participants will receive point-of-care analysis of platelet function and coagulation (laboratory analysis and viscoelastic tests, if not already provided by the responsible anesthesiologist) based on the clinical situation, at different time points before and after retransfusion of processed cell salvage blood.",[9],{"type":21,"name":26,"description":23,"armGroupLabels":27,"otherNames":11},"Autologous cell salvage with i-Sep SAME device",[15],[29],{"name":30,"affiliation":31,"role":32},"Gabor Erdoes, MD","University of Bern","STUDY_CHAIR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Fabio Barattiero, MD","CONTACT","004131632111","fabio.barattiero@insel.ch",{"name":30,"role":36,"phone":37,"phoneExt":11,"email":40},"gabor.erdoes@insel.ch",[42],{"facility":43,"status":44,"city":45,"state":11,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Department of Anesthesiology and Pain Medicine","RECRUITING","Bern","3010","Switzerland","CH",{"type":50,"coordinates":51},"Point",[52,53],7.44744,46.94809,{"lat":53,"lon":52},[56],{"name":57,"role":36,"phone":58,"phoneExt":11,"email":40},"Gabor Erdoes, MD PhD","0041316322726",{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[62,64],{"name":63,"class":6},"University Hospital, Geneva",{"name":65,"class":6},"University of Zurich","100547249","platelet-function-after-cardiac-surgery-100547249",false,"NCT06405516","Platelet Function After Cardiac Surgery.","Platelet Count and Function After Usage of Two Different Cell Saver Devices During Cardiac Surgery: a Randomized Controlled Multi-center Equivalence Trial.","PLFICS","Inclusion Criteria:\n\n* Age \\>18 years\n* Elective high risk cardiac surgery with cardiopulmonary bypass usage\n* Cardiopulmonary bypass time \\> 120 minutes\n* Written informed consent\n\nExclusion Criteria:\n\n* Preoperative use of oral or intravenous anti-coagulants or antiplatelet agents (except aspirin)\n* Inability to understand and sign the informed consent form (e.g. language problems, dementia, mental disorders).","ALL","18 Years",{"count":77,"type":78},40,"ESTIMATED","INTERVENTIONAL",[81],"NA","Intraoperative cell salvage is commonly used in cardiac surgery to reduce the administration of allogeneic red blood cells and thus improve the outcome for the patient. When processing the salvaged blood, however, a large part of the patient's plasma is washed out. This is a disadvantage with regard to an optimal coagulation situation after cardiac surgery.\n\nThere are currently various cell saver systems on the market. According to the manufacturers, the plasma is returned to the patient in different quantities as part of the processing procedure. Thus, it can be assumed that in addition to red blood cells, platelets (part of plasma) are retransfused and contribute to an optimized coagulation. Unfortunately, there is a lack of studies in this regard in the cardiac surgery population.\n\nThe investigators aim to study the performance of two different cell saver devices regarding preservation of platelet number and function.",[84],"Platelet Dysfunction","2025-06-03",{"date":87,"type":88},"2025-06-06","ACTUAL",{"date":90,"type":88},"2024-06-12",{"date":92,"type":78},"2026-01-01",{"name":5,"class":6},1]