Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass

University of Miami

Status and phase: Completed; Phase 4

Conditions: Coagulation; Intravascular

Treatments: Drug: Protamine fixed dose; Drug: Protamine ratio dose

Study type: Interventional

Funder types: Other

Identifiers

NCT05426031

20220234

Details and patient eligibility

About

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

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Fixed Dose Protamine group

Experimental group

Description:

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.

Treatment:

Drug: Protamine fixed dose

Ratio Dose Protamine Group

Active Comparator group

Description:

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.

Treatment:

Drug: Protamine ratio dose