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

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

Study Overview

• Status: Completed
• Conditions: Coagulation; Intravascular
• Intervention / Treatment: Drug: Protamine fixed dose; Drug: Protamine ratio dose

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
    • Miami, Florida, United States, 33136
      • University of Miami Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fixed Dose Protamine group; Participants in the group will receive a one time dose of 250 mg Protamine to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery.	Drug: Protamine fixed dose; 250 mg of protamine intravenously (IV), one time use
Active Comparator: Ratio Dose Protamine Group; Participants in the group will receive a ratio dose of Protamine in a 1mg per 100 units of heparin ratio to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery.	Drug: Protamine ratio dose; 1mg of protamine per 100 units of heparin given intravenously (IV), one time use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activated Clotting Time	Activated clotting times will be measured using standard coagulation monitor	Baseline (before start of surgery)
Activated Clotting Time	Activated clotting times will be measured using standard coagulation monitor	up to 4 hours (after cardiopulmonary bypass surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional Protamine Dosing	Additional protamine dose will be measured in milligrams (mg)	Up to 4 hours
Chest Tube Output	Measured in milliliters (ml)	Up to 24 hours
Count of Participants Receiving Red Blood Cell Transfusion	All transfusions were recorded in a data log for the count of participants that received a red blood cell transfusion.	Up to 4 hours

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Michael Fabbro, DO, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Coagulants; Heparin Antagonists; Protamines
• Other Study ID Numbers: 20220234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No