Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation
Boston Children's Hospital
30 participants
Jul 12, 2018
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- pediatric patient (age less than 18 years)
- weight > 3kg
- scheduled to undergo 1) cardiac catheterization, 2)cardiac surgical procedure utilizing CPB, and/or 3) the institution of extracorporeal support
- must already require the administration of bivalirudin as part of their treatment plan
Exclusion Criteria3
- Age equal to or greater than 18 years,
- weight less than 3kg
- end-stage renal failure requiring renal replacement therapy.
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Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT03532399