Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation
ConditionDrug Effect
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age equal to or greater than 18 years,
weight less than 3kg
end-stage renal failure requiring renal replacement therapy.
Trial population
Pediatric (age less than 18 years and more than 3kg) patients who present to Boston Children's Hospital (BCH) for cardiac catheterization, a cardiac surgical procedure utilizing CPB, or the institution of extracorporeal support and who require the administration of bivalirudin as part of their treatment plan will be included.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Bivalirudin
DrugCPB: 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 to the patient as 0.75mg/kg IV bolus followed by a 1.75mg/kg/hr infusion for the length of the procedure. Changes in infusion rate or bolus dosing during the procedure and post-procedure will be at the discretion of the patient's care providers. ECMO/VAD: Dosing will be informed by the hospital's formulary recommendations(http://online.lexi.com/lco/action/doc/retrieve/docid/chibos\_f/6317841), but will ultimately be determined by patient's primary provider.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Pediatric Cardiac Catheterization1 intervention
Group B: Pediatric Cardiac Surgery1 intervention
Group C: Pediatric Extracorporeal Life Support (ECLS)1 intervention
Trial outcomes
Primary outcomes
1
Plasma Bivalirudin Concentration
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.
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 outcomes
1
thrombotic complications
arterial, venous, and/or CPB/ECMO/VAD thrombosis; embolic stroke
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.2
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.3
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov