Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bivalirudin.
- Who it may be relevant to
- Registry conditions: Drug Effect. Basic parameters: up to 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Bivalirudin
CPB: Per hospital protocol, bivalirudin 1 mg/kg IV will be administered to the patient 10 minutes prior to the start of CPB along with an infusion of bivalirudin at 2.5 mg/kg/hr. Additional bolus doses of 0.5 to 1 mg/kg will be administered for ACTs less than the specified target (either 2 times baseline ACT or \> 400 seconds per the discretion of the patient's providers). 50mg of bivalirudin will be administered to the bypass circuit. Cardiac Catheterization: Bivalirudin will be administered t
Primary outcome measures
- Plasma Bivalirudin Concentration [Time frame: 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.]
Secondary outcome measures (3)
- thrombotic complications [Time frame: 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.]
- bleeding in excess of expectations for a given procedure or ECLS modality [Time frame: 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 [Time frame: 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.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Boston Children's Hospital — Boston
Identifiers
NCT: NCT03532399 · IRB-P00027930