Measuring how bivalirudin works in children during heart procedures
Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation
This study is testing how the blood thinner bivalirudin works in children during heart procedures to help make sure they get the right amount for safety and effectiveness.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03532399 on ClinicalTrials.gov |
What this trial studies
This observational study aims to measure the plasma concentrations of bivalirudin in pediatric patients who are undergoing cardiac catheterization or surgical procedures that involve cardiopulmonary bypass or extracorporeal support. By focusing on children under 18 years old who require bivalirudin as part of their treatment, the study seeks to understand the pharmacokinetics of this anticoagulant in a pediatric setting. The findings could help optimize dosing and improve safety and efficacy in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients under 18 years old who weigh more than 3 kg and are scheduled for specific cardiac procedures requiring bivalirudin.
Not a fit: Patients aged 18 years or older, those weighing less than 3 kg, or those with end-stage renal failure requiring renal replacement therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better dosing guidelines for bivalirudin in pediatric patients, enhancing their safety during cardiac procedures.
How similar studies have performed: While there may be limited studies specifically on bivalirudin in pediatric populations, similar pharmacokinetic studies in adults have shown promising results, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Zaleski L Zaleski, MD
- Email: katherine.zaleski@childrens.harvard.edu
- Phone: 6173557737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.