Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass

Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass: A Blinded Randomized Control Trial Comparing Two Strategies

NCT05426031•University of Miami

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (2)

University of Miami Hospital

Miami, Florida, United States

University of Miami

Miami, Florida, United States

Key Dates

Start Date

June 28, 2022

Primary Completion Date

June 1, 2023

Completion Date

June 1, 2023

Last Updated

August 13, 2024

Enrollment

130

ACTUAL participants

Conditions

Coagulation; Intravascular

Interventions

Protamine fixed dose

DRUG

Protamine ratio dose

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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