Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation

Drug Effect Clinical Trial

Official title:

Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03532399
• Other study ID #: IRB-P00027930
• Status: Recruiting
• Start date: July 12, 2018
• Est. completion date: May 2026

Study information

• Verified date: June 2024
• Source: Boston Children's Hospital
• Contact: Zaleski L Zaleski, MD
• Phone: 6173557737
• Email: katherine.zaleski[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Effect

Intervention

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 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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	thrombotic complications	arterial, venous, and/or CPB/ECMO/VAD thrombosis; embolic stroke	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.
Secondary	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.
Secondary	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.