Bivalirudin as a Procedural Anticoagulant in Pediatrics

The Medicines Company

Status and phase

Completed

Phase 2

Conditions

Cardiology

Treatments

Drug: bivalirudin

Study type

Interventional

Funder types

Industry

Identifiers

TMC-BIV-07-01

Details and patient eligibility

About

Pharmacokinetics and safety of weight based bivalirudin in children

Enrollment

110 patients

Sex

All

Ages

Under 16 years old

Volunteers

No Healthy Volunteers

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.