Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation

NCT03532399 | Recruiting FDA Drug

• 1 other identifier: IRB-P00027930
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Bivalirudin

Outcome Measures

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.

  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 (3)

• thrombotic complications

  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

  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

  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.

Study Arms (3)

Pediatric Cardiac Catheterization

Drug: Bivalirudin

Pediatric Cardiac Surgery

Drug: Bivalirudin

Pediatric Extracorporeal Life Support (ECLS)

Drug: Bivalirudin

Interventions

Bivalirudin DRUG

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.

Pediatric Cardiac Catheterization; Pediatric Cardiac Surgery; Pediatric Extracorporeal Life Support (ECLS)

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02116, United States

RECRUITING

MeSH Terms

Interventions

bivalirudin

Central Study Contacts

Zaleski L Zaleski, MD

CONTACT

6173557737; katherine.zaleski@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Anaesthesia

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 22, 2018
• Study Start: July 12, 2018
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)