[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629692":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":57,"collaborators":40,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":40,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":40,"enrollmentInfo":69,"targetDuration":40,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":45,"whyStopped":40,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Sohag University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Protamine Dose (1:1)","ACTIVE_COMPARATOR","Participants will receive protamine sulfate at a ratio of 1 mg per 100 IU of the initial heparin dose administered during cardiopulmonary bypass. Protamine will be administered intravenously over 5-10 minutes at the termination of cardiopulmonary bypass for heparin reversal.",[13],"Drug: Protamine sulfate",{"label":15,"type":16,"description":17,"interventionNames":18},"Reduced Protamine Dose (0.8:1)","EXPERIMENTAL","Participants will receive protamine sulfate at a ratio of 0.8 mg per 100 IU of the initial heparin dose administered during cardiopulmonary bypass. Protamine will be administered intravenously over 5-10 minutes at the termination of cardiopulmonary bypass for heparin reversal.",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"Reduced Protamine Dose (0.75:1)","Participants will receive protamine sulfate at a ratio of 0.75 mg per 100 IU of the initial heparin dose administered during cardiopulmonary bypass. Protamine will be administered intravenously over 5-10 minutes at the termination of cardiopulmonary bypass for heparin reversal.",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Protamine sulfate","Protamine sulfate will be administered intravenously for reversal of heparin anticoagulation after cardiopulmonary bypass. The dose will be calculated according to the randomized study group based on the initial heparin dose administered during cardiopulmonary bypass.",[20,15,9],[30],"Protamine",[32],{"name":33,"affiliation":34,"role":35},"Asmaa S Farghaly, MD","Faculty of Medicine, Sohag University","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","+20 10 20283823",null,"asmaasaad@med.sohag.edu.eg",[43],{"facility":44,"status":45,"city":46,"state":40,"zip":40,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Sohag University Hospital","RECRUITING","Sohag","Egypt","EG",{"type":50,"coordinates":51},"Point",[52,53],31.69478,26.55695,{"lat":53,"lon":52},[56],{"name":33,"role":38,"phone":39,"phoneExt":40,"email":41},{"type":35,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Asmaa Saadeldeen Farghaly Gadallah","Lecturer of Anesthesia, Intensive Care and Pain Management. Faculty of Medicine","100629692","dose-for-reversal-of-heparin-after-cardiopulmonary-bypass-100629692",false,"NCT07477977","Dose for Reversal of Heparin After Cardiopulmonary Bypass","Lower Protamine Dose for Reversal of Heparin After Cardiopulmonary Bypass: Is it Safe? Comparative Prospective Randomized Trial.","Inclusion Criteria:\n\n* Age ≥18 years\n* Patients scheduled for elective cardiac surgery requiring cardiopulmonary bypass (CABG, valve surgery, or combined procedures)\n* Patients receiving systemic heparinization according to the institutional cardiopulmonary bypass protocol\n* Ability to provide written informed consent before surgery\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to protamine\n* Pre-existing coagulopathy or bleeding disorders\n* Patients receiving chronic anticoagulation that cannot be safely discontinued before surgery\n* Severe renal dysfunction\n* Severe hepatic dysfunction\n* Emergency cardiac surgery\n* Pregnancy\n* Off-pump cardiac surgery","ALL","18 Years",{"count":70,"type":71},195,"ESTIMATED","INTERVENTIONAL",[74],"NA","Protamine sulfate is routinely used to reverse heparin anticoagulation after cardiopulmonary bypass (CPB). The conventional dosing strategy of 1 mg protamine per 100 IU of heparin may result in excess protamine exposure, which has been associated with anticoagulant effects, platelet dysfunction, and hemodynamic instability. Recent evidence suggests that lower protamine doses may provide adequate heparin reversal while reducing potential adverse effects. \n\nThis multicenter, prospective, randomized, double-blind, controlled trial aims to compare three protamine-to-heparin dosing ratios (1:1, 0.8:1, and 0.75:1) in adult patients undergoing elective cardiac surgery requiring cardiopulmonary bypass. The primary outcome is activated clotting time (ACT) measured 5 minutes after protamine administration. Secondary outcomes include the need for additional protamine administration, protamine-related adverse events, postoperative bleeding, blood product transfusion requirements, and length of intensive care unit stay. \n\nThe results of this study may help determine whether reduced protamine dosing can safely achieve effective heparin reversal while minimizing drug exposure and potential complications after cardiopulmonary bypass. ",[77],"Open Heart Surgery",[30,79,80,81,82],"Heparin","Activated clotting time","Postoperative bleeding","Cardiac surgery","2026-05-04",{"date":85,"type":86},"2026-05-05","ACTUAL",{"date":88,"type":86},"2026-03-01",{"date":90,"type":71},"2026-09-01",{"name":5,"class":6},1]