Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation
- Registration Number
- NCT03532399
- Lead Sponsor
- Boston Children's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pediatric Cardiac Surgery Bivalirudin - Pediatric Extracorporeal Life Support (ECLS) Bivalirudin - Pediatric Cardiac Catheterization Bivalirudin -
- Primary Outcome Measures
Name Time Method Plasma Bivalirudin Concentration Throughout the duration of treatment with bivalirudin and for one hour after the infusion is stopped. To be specific: 1. In CPB and cath lab cases arm: average 6 hours. 2. In ECLS arm: average 10 days. The primary end-point will be the plasma bivalirudin concentration (nanogram/mL) measured at multiple set time-points throughout the administration of bivalirudin in order to delineate the pharmacokinetic profile in the pediatric population.
- Secondary Outcome Measures
Name Time Method thrombotic complications Data will be assessed continuously in the procedural groups throughout the duration of the infusion and then continued weekly throughout the length of the hospital stay up to one year from enrollment. arterial, venous, and/or CPB/ECMO/VAD thrombosis; embolic stroke
bleeding in excess of expectations for a given procedure or ECLS modality Data will be assessed continuously in the procedural groups throughout the duration of the infusion and then continued weekly throughout the length of the hospital stay up to one year from enrollment. mortality Data will be assessed continuously in the procedural groups throughout the duration of the infusion and then continued weekly throughout the length of the hospital stay or until death up to one year from enrollment.
Trial Locations
- Locations (1)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States