Actively Recruiting
Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation
Led by Boston Children's Hospital · Updated on 2025-07-02
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the drug bivalirudin behaves in the blood of pediatric patients needing blood thinning during heart procedures. This includes children undergoing cardiac catheterization, heart surgery with cardiopulmonary bypass (CPB), or using life support devices such as extracorporeal membrane oxygenation (ECMO) or ventricular assist devices (VAD). The goal is to understand the drug's levels and effects in these specific medical situations. The study observes children who already require bivalirudin as part of their care. Dosing varies by procedure: for CPB, an initial intravenous dose is given 10 minutes before bypass, followed by a continuous infusion, with extra doses if needed. During cardiac catheterization, a bolus dose is followed by an infusion for the procedure's duration. For ECMO or VAD support, dosing follows hospital guidelines but is tailored by the care team. The study does not assign treatments but monitors these real-world uses. Participants will have their blood tested to measure bivalirudin levels during treatment and for a short time after stopping the drug, varying by procedure length. Researchers will also track blood clotting problems, unexpected bleeding, and survival continuously during treatment and up to one year after enrollment. The study involves ongoing monitoring while in the hospital and long-term follow-up to assess safety and drug behavior over time.
CONDITIONS
Brief Title
Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patient under 18 years old
- Weight greater than 3 kilograms
- Scheduled for cardiac catheterization, cardiac surgery with cardiopulmonary bypass, or extracorporeal support
- Already require bivalirudin as part of treatment plan
You will not qualify if you...
- Age 18 years or older
- Weight less than 3 kilograms
- End-stage renal failure requiring renal replacement therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 hours for catheterization and surgery; up to 10 days for ECLS
Participants receive bivalirudin according to hospital protocol during cardiac catheterization, cardiac surgery with cardiopulmonary bypass, or extracorporeal life support (ECLS).
1 procedure visit with continuous monitoring during treatment
Duration - Up to 1 year after treatment
Participants are monitored weekly for up to one year after treatment for thrombotic complications, bleeding, and mortality.
Weekly visits for up to 1 year
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02116
Actively Recruiting
Research Team
Z
Zaleski L Zaleski, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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