Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation

Boston Children's Hospital

Status: Enrolling

Conditions: Drug Effect

Treatments: Drug: Bivalirudin

Study type: Observational

Funder types: Other

Identifiers

NCT03532399

IRB-P00027930

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 3 patient groups

Pediatric Cardiac Catheterization

Treatment:

Drug: Bivalirudin

Pediatric Cardiac Surgery

Treatment:

Drug: Bivalirudin

Pediatric Extracorporeal Life Support (ECLS)

Treatment:

Drug: Bivalirudin