RECRUITING

Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation

Quick Facts

Study Start:2018-07-12
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03532399

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * pediatric patient (age less than 18 years)
  2. * weight \> 3kg
  3. * scheduled to undergo 1) cardiac catheterization, 2)cardiac surgical procedure utilizing CPB, and/or 3) the institution of extracorporeal support
  4. * must already require the administration of bivalirudin as part of their treatment plan
  1. * Age equal to or greater than 18 years,
  2. * weight less than 3kg
  3. * end-stage renal failure requiring renal replacement therapy.

Contacts and Locations

Study Contact

Zaleski L Zaleski, MD
CONTACT
6173557737
katherine.zaleski@childrens.harvard.edu

Study Locations (Sites)

Boston Children's Hospital
Boston, Massachusetts, 02116
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-07-12
Study Completion Date2026-05

Study Record Updates

Study Start Date2018-07-12
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • Bivalirudin

Additional Relevant MeSH Terms

  • Drug Effect