Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass

NCT05426031 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20220234
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Coagulation; Intravascular

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Additional Protamine Dosing

  Up to 4 hours

• Chest Tube Output

  Up to 24 hours

• Count of Participants Receiving Red Blood Cell Transfusion

  Up to 4 hours

Study Arms (2)

Fixed Dose Protamine group

EXPERIMENTAL

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

Ratio Dose Protamine Group

ACTIVE COMPARATOR

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

Interventions

Protamine fixed dose DRUG

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

Fixed Dose Protamine group

Protamine ratio dose DRUG

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

Ratio Dose Protamine Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (2)

University of Miami Hospital

Miami, Florida, 33136, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Thrombosis

Interventions

Protamines

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nuclear Proteins; Proteins; Amino Acids, Peptides, and Proteins; Nucleoproteins

Results Point of Contact

• Title: Michael Fabbro II, DO
• Organization: University of Miami

mxf790@miami.edu

305-689-1106

Study Officials

• Michael Fabbro, DO

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: June 28, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)