Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass (NCT05426031) | Clinical Trial Compass
CompletedPhase 4
Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass
United States130 participantsStarted 2022-06-28
Plain-language summary
The purpose of this study is to compare two different dosing strategies of a drug named protamine.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Activated Clotting Time
Timeframe: Baseline (before start of surgery)
2
Activated Clotting Time
Timeframe: up to 4 hours (after cardiopulmonary bypass surgery)