Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Treatments: Protamines

Criteria

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.