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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05426031
Other study ID # 20220234
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 28, 2022
Est. completion date June 1, 2023

Study information

Verified date June 2023
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Protamine fixed dose
250 mg of protamine intravenously (IV), one time use
Protamine ratio dose
1mg of protamine per 100 units of heparin given intravenously (IV), one time use

Locations

Country Name City State
United States University of Miami Miami Florida
United States University of Miami Hospital Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in activated clotting time Activated clotting times will be measured using standard coagulation monitor Baseline (before start of surgery), up to 4 hours (after cardiopulmonary bypass srugery)
Secondary Additional protamine dosing Additional protamine dose will be measured in milligrams (mg) Up to 4 hours
Secondary Chest tube output Measured in milliliters (ml) Up to 24 hours
Secondary Units of red blood cells transfused measured in units Up to 4 hours
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