Measuring how bivalirudin works in children during heart procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Xiqing plus probiotics to improve gut balance and drug effects in chronic kidney disease

  This trial will test whether adding Xiqing and probiotics helps lower nitrogen waste and improve drug effectiveness in adults with stage 3–5 chronic kidney disease who are not on dialysis.

  Recruiting Phase 4 Tongji Hospital · Wuhan, Hubei · NCT07182942

• GLP-1 drug effects on muscle and bone during weight loss

  It tests whether GLP-1–based weight-loss medication (tirzepatide) plus a lifestyle program changes muscle and bone in adults 18–50 with obesity (BMI 30–40).

  Recruiting Phase 4 Pennington Biomedical Research Center · Baton Rouge, Louisiana and 1 other locations · NCT07154719

• Tenecteplase versus alteplase before mechanical thrombectomy for acute large-vessel ischemic stroke

  This trial tests whether tenecteplase given before mechanical thrombectomy helps adults with acute large-vessel ischemic stroke within 4.5 hours recover better than standard alteplase.

  Recruiting Phase 3 Xuanwu Hospital, Beijing · Beijing, Beijing Municipality · NCT06658197

• Comparing morning versus bedtime aspirin for cardiovascular health

  This study is testing if taking aspirin at bedtime works better than taking it in the morning for people who are already using aspirin to protect their heart health.

  Recruiting Phase 4 Herlev and Gentofte Hospital · Hellerup · NCT05932472

• Optimizing meropenem administration in ICU patients

  This study tests if giving the antibiotic meropenem in smaller, more frequent doses can work just as well for ICU patients with serious infections as the standard larger doses.

  Recruiting Oslo University Hospital · Oslo · NCT05578586

• Observing genetic factors in Indian children with leukemia

  This study looks at how genetic differences might affect side effects from chemotherapy in Indian children with leukemia to see how it impacts their quality of life.

  Recruiting at 2 sites University of Geneva, Switzerland · New Delhi and 1 other locations · NCT05512169

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.