NCT03532399 Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation
| NCT ID | NCT03532399 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Drug Effect |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2018-07-12 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2018-07-12 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03532399 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Drug Effect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03532399 currently recruiting?
Yes, NCT03532399 is actively recruiting participants. Contact the research team at katherine.zaleski@childrens.harvard.edu for enrollment information.
Where is the NCT03532399 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT03532399 clinical trial?
NCT03532399 is sponsored by Boston Children's Hospital. The trial plans to enroll 30 participants.