Bivalirudin as a Procedural Anticoagulant in Pediatrics
November 8, 2011 updated by: The Medicines Company
Bivalirudin (Angiomax®) As A Procedural Anticoagulant In The Pediatric Population Undergoing Intravascular Procedures For Congenital Heart Disease
Pharmacokinetics and safety of weight based bivalirudin in children
Study Overview
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Phase 2
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.
Eligibility Criteria
Ages Eligible for Study
No older than 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
PK/PD and safety
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
July 16, 2007
First Submitted That Met QC Criteria
July 17, 2007
First Posted (Estimate)
July 18, 2007
Study Record Updates
Last Update Posted (Estimate)
November 10, 2011
Last Update Submitted That Met QC Criteria
November 8, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMC-BIV-07-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.