Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation
ConditionDrug Effect
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorBoston Children's Hospital
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Age equal to or greater than 18 years,
weight less than 3kg
end-stage renal failure requiring renal replacement therapy.
Trial design
Treatments tested in this trial
- Bivalirudin
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov