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OpenTrials
Completed

NCT Number: NCT05426031

Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass

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

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Key information

Conditions

Coagulation; Intravascular Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Protamine fixed dose

Drug

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

Protamine ratio dose

Drug

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

Primary outcomes

  1. Activated Clotting Time

    Time frame: Baseline (before start of surgery)

    Activated clotting times will be measured using standard coagulation monitor

  2. Activated Clotting Time

    Time frame: up to 4 hours (after cardiopulmonary bypass surgery)

    Activated clotting times will be measured using standard coagulation monitor

Secondary outcomes

  1. Additional Protamine Dosing

    Time frame: Up to 4 hours

    Additional protamine dose will be measured in milligrams (mg)

  2. Chest Tube Output

    Time frame: Up to 24 hours

    Measured in milliliters (ml)

  3. Count of Participants Receiving Red Blood Cell Transfusion

    Time frame: Up to 4 hours

    All transfusions were recorded in a data log for the count of participants that received a red blood cell transfusion.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 21, 2022
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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