Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass

Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass: A Blinded Randomized Control Trial Comparing Two Strategies

The purpose of this study is to compare two different dosing strategies of a drug named protamine.

Inclusion Criteria:

• Patients greater than or equal to 18 years of age undergoing elective cardiac surgery with cardiopulmonary bypass.
• Patients must that have a calculated protamine dose greater than 250 mg based on standard 1:1 initial heparin to protamine dosing calculation.

Exclusion Criteria:

• Patients who are under 18 years of age or pregnant.
• Patients undergoing emergency surgery (ASA class E).
• Patients with known coagulation disorders.
• Patients requiring circulatory arrest or deep hypothermia.
• Patients who have not had the appropriate interruption in coumadin, direct oral anticoagulants or non-aspirin antiplatelet agents.
• Patients on pre-operative intravenous unfractionated heparin infusions.
• Patients ineligible for heparin administration due to known adverse reactions including allergy or heparin induced thrombocytopenia or known heparin resistance.
• Patients who are unable to provide informed consent in the form of a signature.
• History of adverse reaction to protamine.
• Have any condition that, in the opinion of the investigator, will compromise the well-being of the patient or the study, or prevent the patient from meeting or performing study requirements.