Coagulation; Intravascular Clinical Trial
Official title:
Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass: A Blinded Randomized Control Trial Comparing Two Strategies
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 |
Verified date | June 2023 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare two different dosing strategies of a drug named protamine.
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Miami | Miami | Florida |
United States | University of Miami Hospital | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami |
United States,
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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