Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass

Completed · Phase 4

Conditions studied: Coagulation; Intravascular

In brief

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

Key facts

Study ID: NCT05426031
Run by: University of Miami
People needed: 130
Starts: 2022-06-28
Expected to finish: 2023-06-01
Last updated by the study team: 2024-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of Miami Hospital — Miami, Florida, United States
University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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