[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643230":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":10,"responsibleParty":34,"collaborators":10,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":46,"maxAge":10,"enrollmentInfo":47,"targetDuration":50,"studyType":51,"phases":10,"briefSummary":52,"conditions":53,"keywords":59,"overallStatus":69,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":10},{"fullName":5,"class":6},"Hospital de la Santa creu i Sant Pau - Barcelona","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adult Cardiac Surgery With Cardiopulmonary Bypass",null,"Adult patients undergoing elective or urgent cardiac surgery requiring cardiopulmonary bypass who undergo perioperative assessment of flow-based platelet function using the Total Thrombus-formation Analysis System (T-TAS). Participants are evaluated at predefined perioperative time points before surgery, immediately after cardiopulmonary bypass, and 24 hours postoperatively as part of a prospective observational cohort study.",[13],"Diagnostic Test: Total Thrombus-formation Analysis System (T-TAS)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","Total Thrombus-formation Analysis System (T-TAS)","Perioperative assessment of flow-based thrombus formation in whole blood using the Total Thrombus-formation Analysis System (T-TAS), including PL-chip analysis and exploratory AR-chip analysis at predefined perioperative time points during adult cardiac surgery with cardiopulmonary bypass.",[9],[21],{"name":22,"affiliation":23,"role":24},"Tobias Koller, MD, PhD","Instituto de Recerca, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Ana Maria Gomez Caro, MD","CONTACT","+34663266681","agomezc@santpau.cat",{"name":22,"role":28,"phone":32,"phoneExt":10,"email":33},"+34637981674","tkoller@santpau.cat",{"type":24,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Tobias Koller","Head of Cardiac Surgery ICU, MD, PhD","100643230","flow-based-platelet-function-assessment-using-total-thrombus-formation-analysis-system-t-tas-and-early-bleeding-after-cardiac-surgery-with-cardiopulmonary-bypass-cpb-100643230",false,"NCT07619261","Flow-Based Platelet Function Assessment Using Total Thrombus-Formation Analysis System (T-TAS) and Early Bleeding After Cardiac Surgery With Cardiopulmonary Bypass (CPB)","Prospective Observational Study of Flow-Based Platelet Function Using T-TAS and Early Bleeding After Cardiopulmonary Bypass in Adult Cardiac Surgery","TTAS-CPB","Inclusion Criteria:\n\n1. Adults aged 18 years or older\n2. Undergoing elective or urgent cardiac surgery requiring cardiopulmonary bypass\n3. Ability to provide written informed consent\n\nExclusion Criteria:\n\n1. Cardiac surgery performed without cardiopulmonary bypass\n2. Emergency cardiac surgery\n3. Preoperative anticoagulation not reversed at the time of surgery\n4. Refusal or withdrawal of informed consent\n5. Known pregnancy","ALL","18 Years",{"count":48,"type":49},30,"ESTIMATED","2 Days","OBSERVATIONAL","The goal of this observational study is to learn how flow-based platelet function measured with the Total Thrombus-formation Analysis System (T-TAS) relates to early postoperative bleeding in adults undergoing cardiac surgery with cardiopulmonary bypass. The study will also evaluate how T-TAS changes during the perioperative period and how it compares with standard coagulation and platelet function tests.\n\nThe main questions it aims to answer are:\n\nIs lower post-cardiopulmonary bypass T-TAS Platelet-chip (PL-chip) thrombus formation associated with increased postoperative chest tube drainage during the first 12 hours after surgery? How do T-TAS parameters change before surgery, immediately after cardiopulmonary bypass, and 24 hours after surgery? Are abnormal T-TAS results associated with blood transfusion requirements, major bleeding, re-exploration for bleeding, and length of stay in the intensive care unit and hospital? Does T-TAS provide complementary information compared with standard coagulation tests, von Willebrand factor (vWF) measurements, platelet aggregometry, and viscoelastic testing?\n\nParticipants will:\n\nUndergo blood sampling at three predefined perioperative time points:\n\nbefore anesthesia induction, immediately after cardiopulmonary bypass and heparin reversal with protamine, and 24 hours after surgery Have T-TAS testing, standard laboratory coagulation tests, vWF testing, platelet aggregometry, and viscoelastic testing performed on collected samples Have clinical, surgical, transfusion, and postoperative bleeding data collected during their hospital stay\n\nThe study is observational and does not require changes to routine clinical care or perioperative management.",[54,55,56,57,58],"Perioperative Bleeding","Coagulopathy During Cardiac Surgery","Platelet Dysfunction","Cardiac Surgery","Acquired Von Willebrand Disease",[57,60,61,62,63,64,65,66,67,68],"Total Thrombus formation Analysis System (T-TAS)","Platelet Function","Postoperative Bleeding","Hemostasis","Blood Transfusion","ROTEM","Thrombus Formation","Cardiopulmonary Bypass (CPB)","von Willebrand Factor (vWF)","NOT_YET_RECRUITING","2026-06-08",{"date":72,"type":73},"2026-06-10","ACTUAL",{"date":75,"type":49},"2026-09-15",{"date":77,"type":49},"2027-02-15",{"name":5,"class":6}]