Recruiting

Bivalirudin

Sponsor:

Boston Children's Hospital

Code:

NCT03532399

Conditions

Drug Effect

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Bivalirudin

Study Details

Brief 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.

Conditions

Drug Effect

Study ID

NCT03532399

Start date

Jul 12, 2018

Status verified date

Jun, 2025

Completion date

May, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Pediatric Cardiac Catheterization

Pediatric Cardiac Surgery

Pediatric Extracorporeal Life Support (ECLS)

Interventions

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Zaleski L Zaleski, MD

6173557737katherine.zaleski@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02116

More Information

Sponsor

Boston Children's Hospital

Last update posted

Jul 2, 2025

Last verified

Jun, 2025

Keywords

  • Bivalirudin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2025-07-02.