Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass

NCT ID: NCT05426031

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-28
• Study Completion Date: 2023-06-01

Brief Summary

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

Conditions

Coagulation; Intravascular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Protamine fixed dose

Intervention Type: DRUG

250 mg of protamine intravenously (IV), one time use

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.

Group Type: ACTIVE_COMPARATOR

Protamine ratio dose

Intervention Type: DRUG

1mg of protamine per 100 units of heparin given intravenously (IV), one time use

Interventions

Protamine fixed dose

250 mg of protamine intravenously (IV), one time use

Intervention Type: DRUG

Protamine ratio dose

1mg of protamine per 100 units of heparin given intravenously (IV), one time use

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Michael Fabbro

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Fabbro, DO

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami Hospital

Miami, Florida, United States

University of Miami

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20220234

Identifier Type: -

Identifier Source: org_study_id