Bivalirudin as a Procedural Anticoagulant in Pediatrics

Phase 2

Completed

• Conditions: Cardiology

• Registration Number: NCT00503126
• Lead Sponsor: The Medicines Company

Brief Summary

Pharmacokinetics and safety of weight based bivalirudin in children

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-16
• Study First Submitted QC: 2007-07-17
• Study First Posted: 2007-07-18
• Study Start: 2007-08
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-08
• Last Update Posted: 2011-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
PK/PD and safety	30 days