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Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation

Who can join

Up to age 17 · All sexes

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.

About the study

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.

What is being tested

• Bivalirudin (drug)

Sponsor: Boston Children's Hospital · Participants: 30 · Started: Jul 12, 2018

Contact the study team

• Zaleski L Zaleski, MD · Phone: 6173557737

Official record on ClinicalTrials.gov — NCT03532399

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.