Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation

Recruiting now

Conditions studied: Drug Effect

In brief

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 facts

Study ID

NCT03532399

Run by

Boston Children's Hospital

People needed

30

Starts

2018-07-12

Expected to finish

2026-05-01

Last updated by the study team

2025-07-02

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Age equal to or greater than 18 years,
• weight less than 3kg
• end-stage renal failure requiring renal replacement therapy.

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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