Cardiology
Conditions
Keywords
pediatrics, bivalirudin
Brief summary
Pharmacokinetics and safety of weight based bivalirudin in children
Interventions
DRUGbivalirudin
anticoagulation
Sponsors
The Medicines Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
* Male and non-pregnant females, with an age range of birth to 16 years of age. * Expected to undergo a percutaneous intravascular procedure for the management of congenital heart disease. * Written informed consent from a legal guardian/parent. * Life expectancy of at least 15 days at study entry. * Assent of the patient if older than 8 years, whenever possible.
Exclusion criteria
* History of intracerebral bleed (neonates confirmed by an ultrasound head scan prior to procedure), or cerebral arteriovenous malformation or any prior bleed with neurological deficit. * Gastrointestinal or genitourinary bleeding within the last 2 weeks excluding normal menstrual cycles. * Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit. * Known congenital or acquired bleeding or clotting disorder. * Patients undergoing renal dialysis.\* * Weight \< 2.5 kg. * Confirmed pregnancy at time of enrollment or breast feeding (females of child-bearing potential). * Known allergy to bivalirudin or hirudin-derived drugs, or known sensitivity to any component of bivalirudin (Angiomax®). * Any condition that in the investigator's opinion would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements. * Participation in another investigational therapeutic drug or therapeutic device trial within 30 days of starting study. * Patients who have been receiving warfarin (Coumadin®) therapy and whose INR is \> 1.5. * Patients who cannot be discontinued from UFH at least 30 minutes prior to study drug bolus. * Patients who have received a dose of LMWH within 8 hours prior to study drug bolus. * Patients previously enrolled in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK/PD and safety | 30 days |
Outcome results
None listed