Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation
This study measures how the body processes bivalirudin, a blood thinner medication, in children undergoing heart procedures or using heart-lung support machines. Researchers will track the drug's levels in the blood to understand how it works safely in young patients.
Key Objective: This trial aims to establish safe and effective dosing of bivalirudin for children who need anticoagulation during cardiac procedures or mechanical circulatory support.
Who to Consider: Parents of children undergoing cardiac catheterization, cardiac surgery with cardiopulmonary bypass, or requiring ECMO or ventricular support devices should consider this study.
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * Age equal to or greater than 18 years, * weight less than 3kg * end-stage renal failure requiring renal replacement therapy.