Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass

Coagulation; Intravascular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05426031
• Other study ID #: 20220234
• Status: Completed
• Phase: Phase 4
• Start date: June 28, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coagulation; Intravascular

Intervention

Drug:
• Protamine fixed dose
250 mg of protamine intravenously (IV), one time use
• Protamine ratio dose
1mg of protamine per 100 units of heparin given intravenously (IV), one time use

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida
United States	University of Miami Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in activated clotting time	Activated clotting times will be measured using standard coagulation monitor	Baseline (before start of surgery), up to 4 hours (after cardiopulmonary bypass srugery)
Secondary	Additional protamine dosing	Additional protamine dose will be measured in milligrams (mg)	Up to 4 hours
Secondary	Chest tube output	Measured in milliliters (ml)	Up to 24 hours
Secondary	Units of red blood cells transfused	measured in units	Up to 4 hours