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Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation

{ "Understanding Bivalirudin in Children Undergoing Cardiac Procedures", "This study is looking at how the anti-clotting medicine bivalirudin works in children (under 18 years old and weighing over 3kg) who are having heart procedures. These procedures include cardiac catheterization, heart surgery with a heart-lung machine (cardiopulmonary bypass or CPB), or needing life support like ECMO. You would already be receiving bivalirudin as part of your treatment. Researchers will measure the levels of bivalirudin in your blood to understand how your body processes the medicine. This is an observational study, meaning researchers will gather information without changing your treatment plan. The goal is to better understand how to use bivalirudin effectively in children. Up to 30 children are expected to participate.", "design": "This is an observational study involving up to 30 pediatric patients. It is not a randomized or blinded study.", "commitments": "Researchers will collect blood samples to measure bivalirudin levels throughout your treatment, and for one hour after the infusion stops. This could be for about 6 hours in some cases, or up to 10 days in others.", "compensation": "Not stated in the trial record.", "follow_up": "Blood samples will be collected for up to one hour after bivalirudin infusion stops, which could be up to 10 days after starting treatment.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT03532399

Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation

Recruiting
Not specifiedUp to 17Observational
Boston Children's Hospital
~30 participants
Updated 2025-07-02 on ClinicalTrials.gov
What's tested:Bivalirudin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Plasma Bivalirudin Concentration
Measured over 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.

Conditions

Drug Effect

Explore related trials

Heart Disorder

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Zaleski L Zaleski, MD
[email protected]
6173557737
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Eligibility criteria

Inclusion

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

Age equal to or greater than 18 years,
weight less than 3kg
end-stage renal failure requiring renal replacement therapy.

What this trial measures

  • Plasma Bivalirudin ConcentrationThroughout 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.