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Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation
Sponsor: Boston Children's Hospital
Summary
This study will measure plasma concentrations of bivalirudin in pediatric patients undergoing cardiac catheterization, cardiac surgical procedures utilizing cardiopulmonary bypass (CPB), or extracorporeal support with ECMO, ventricular support devices (VAD) or lung-assist devices (LAD). The aim is to understand the pharmacokinetics of bivalirudin in these settings.
Key Details
Gender
All
Age Range
Any - 17 Years
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2018-07-12
Completion Date
2026-05
Last Updated
2025-07-02
Healthy Volunteers
No
Conditions
Interventions
Bivalirudin
CPB: Per hospital protocol, bivalirudin 1 mg/kg IV will be administered to the patient 10 minutes prior to the start of CPB along with an infusion of bivalirudin at 2.5 mg/kg/hr. Additional bolus doses of 0.5 to 1 mg/kg will be administered for ACTs less than the specified target (either 2 times baseline ACT or \> 400 seconds per the discretion of the patient's providers). 50mg of bivalirudin will be administered to the bypass circuit. Cardiac Catheterization: Bivalirudin will be administered to the patient as 0.75mg/kg IV bolus followed by a 1.75mg/kg/hr infusion for the length of the procedure. Changes in infusion rate or bolus dosing during the procedure and post-procedure will be at the discretion of the patient's care providers. ECMO/VAD: Dosing will be informed by the hospital's formulary recommendations(http://online.lexi.com/lco/action/doc/retrieve/docid/chibos\_f/6317841), but will ultimately be determined by patient's primary provider.
Locations (1)
Boston Children's Hospital
Boston, Massachusetts, United States