Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass

Phase 4

Completed

• Conditions: Coagulation; Intravascular
• Interventions: Drug: Protamine fixed dose; Drug: Protamine ratio dose

• Registration Number: NCT05426031
• Lead Sponsor: University of Miami

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-15
• Study First Posted: 2022-06-21
• Study Start: 2022-06-28
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Results First Submitted: 2024-05-31
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-18
• Last Update Submitted: 2024-07-18
• Results First Posted: 2024-08-13
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed Dose Protamine group	Protamine fixed dose	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.
Ratio Dose Protamine Group	Protamine ratio dose	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.

Primary Outcome Measures

Name	Time	Method
Activated Clotting Time	up to 4 hours (after cardiopulmonary bypass surgery)	Activated clotting times will be measured using standard coagulation monitor

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University of Miami Hospital; 🇺🇸 Miami, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States