Current Environment:

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.

Conditions

Drug Effect

Recruitment Status

Recruiting

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.

Intervention

Intervention Type

Intervention Name

Drug

Bivalirudin

Gender

All

Min Age

N/A

Max Age

17 Years

Download Date

September 8, 2022

Principal Investigator

Katherine Zaleski

Primary Contact Information

Zaleski L Zaleski, MD

6173557737

katherine.zaleski@childrens.harvard.edu

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: