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Dose for Reversal of Heparin After Cardiopulmonary Bypass

RecruitingNAAges 18 Years - anyAllSohag University
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In plain words

What the trial is, and whether it could suit you

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. ๏ฟผ 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-rela

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 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 Exclusion Criteria: * 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 * Severe hepatic dysfunction * Emergency cardiac surgery * Pregnancy * Off-pump cardiac surgery
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What it tests

  • Protamine sulfate
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Where

1 site
Sohag University Hospital
Sohag, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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