Status:
COMPLETED
Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass
Lead Sponsor:
University of Miami
Conditions:
Coagulation; Intravascular
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare two different dosing strategies of a drug named protamine.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05426031
Start Date
June 28 2022
End Date
June 1 2023
Last Update
August 13 2024
Active Locations (2)
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1
University of Miami Hospital
Miami, Florida, United States, 33136
2
University of Miami
Miami, Florida, United States, 33136