NCT03532399Recruiting

Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation

Boston Children's Hospital

Start Date

7/12/2018

Completion Date

5/1/2026

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

Age Range: No minimum to 17 years

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.

Interventions

DRUG

Bivalirudin

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Conditions

Drug Effect

Locations

Boston Children's Hospital

Boston, Massachusetts 02116

United States