Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass

Sponsor

University of Miami (Other)

Overall Status

Recruiting

CT.gov ID

NCT05426031

Collaborator

(none)

130

Enrollment

Locations

Arms

12.1

Anticipated Duration (Months)

Patients Per Site

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coagulation; Intravascular	Drug: Protamine fixed dose Drug: Protamine ratio dose	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 28, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in activated clotting time [Baseline (before start of surgery), up to 4 hours (after cardiopulmonary bypass srugery)]
Activated clotting times will be measured using standard coagulation monitor

Secondary Outcome Measures

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)
Units of red blood cells transfused [Up to 4 hours]
measured in units

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Hospital	Miami	Florida	United States	33136
2	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

University of Miami

Investigators

Principal Investigator: Michael Fabbro, DO, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Fabbro, Associate Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT05426031

Other Study ID Numbers:

20220234

First Posted:

Jun 21, 2022

Last Update Posted:

Jul 29, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Protamines

Study Results

No Results Posted as of Jul 29, 2022