Pharmacokinetics and safety of weight based bivalirudin in children

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.