Dose for Reversal of Heparin After Cardiopulmonary Bypass
ConditionOpen Heart Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSohag University
About this trial
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. 
This 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. 
The 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. 
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Patients scheduled for elective cardiac surgery requiring cardiopulmonary bypass (CABG, valve surgery, or combined procedures)
Patients receiving systemic heparinization according to the institutional cardiopulmonary bypass protocol
Ability to provide written informed consent before surgery
Disqualifiers
Known allergy or hypersensitivity to protamine
Pre-existing coagulopathy or bleeding disorders
Patients receiving chronic anticoagulation that cannot be safely discontinued before surgery
Severe renal dysfunction
Trial design
Design model
Parallel
Treatments tested in this trial
Protamine sulfate
DrugProtamine 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.
Treatment groups
195 Participants
are divided into 3 treatment groupsGroup A: Standard Protamine Dose (1:1)Active comparator 1 intervention
Group B: Reduced Protamine Dose (0.8:1)Experimental treatment 1 intervention
Group C: Reduced Protamine Dose (0.75:1)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Post-protamine Activated Clotting Time (ACT)
Activated clotting time measured 5 minutes after completion of protamine administration to assess adequacy of heparin reversal after cardiopulmonary bypass.
Time frame
5 minutes after protamine administrationSecondary outcomes
1
Need for additional protamine administration
Requirement for additional protamine if activated clotting time exceeds 130 seconds after initial protamine administration.
Time frame
5 minutes after initial protamine administration2
Postoperative chest tube drainage
Total volume of chest tube drainage measured during the first 24 hours after cardiac surgery.
Time frame
Within 24 hours after surgery3
Blood transfusion requirements
Total number of blood product units (red blood cells, fresh frozen plasma, platelets, or cryoprecipitate) transfused within the first 24 hours after surgery.
Time frame
Within 24 hours after surgery4
Protamine-related adverse events
Incidence of protamine-related adverse events including hypotension requiring vasopressors, allergic reactions, or anaphylaxis.
Time frame
From protamine administration until 24 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov