Bivalirudin for Children Undergoing Heart Procedures

Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation

Recruiting Observational Study
Drug Effect
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
Up to 17
Sex
Any
Study type
Observational
Participants needed
30 (estimated)
Sponsor
Boston Children's Hospital · Other
Who this trial is looking for

This trial is looking for children under 18 who need a specific blood thinner called bivalirudin during heart procedures. Participants will help researchers understand how this medication works in younger patients.

Are You a Good Fit for This Trial?
Must be taking Bivalirudin

You may be able to join if

  • I am a pediatric patient under 18 years old.
  • I weigh more than 3 kg.
  • I am scheduled for a heart procedure or support.
  • I need to receive bivalirudin as part of my treatment.

You may not be able to join if

  • I am 18 years old or older.
  • I weigh less than 3 kg.
  • I have end-stage renal failure needing dialysis.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

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.

Trial Locations
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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 the…
Contacts

Zaleski L Zaleski, MD

6173557737

katherine.zaleski@childrens.harvard.edu

CONTACT