Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass

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

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

Conditions
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Coagulation; Intravascular

Intervention / Treatment
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* Drug: Protamine fixed dose
* Drug: Protamine ratio dose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed Dose Protamine group<br>Participants in the group will receive a one time dose of 250 mg Protamine to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery. | Drug: Protamine fixed dose<br>* 250 mg of protamine intravenously (IV), one time use<br>|
| Active Comparator: Ratio Dose Protamine Group<br>Participants in the group will receive a ratio dose of Protamine in a 1mg per 100 units of heparin ratio to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery. | Drug: Protamine ratio dose<br>* 1mg of protamine per 100 units of heparin given intravenously (IV), one time use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in activated clotting time | Activated clotting times will be measured using standard coagulation monitor | Baseline (before start of surgery), up to 4 hours (after cardiopulmonary bypass srugery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional protamine dosing | Additional protamine dose will be measured in milligrams (mg) | Up to 4 hours | 
| Chest tube output | Measured in milliliters (ml) | Up to 24 hours | 
| Units of red blood cells transfused | measured in units | Up to 4 hours |