Bivalirudin as a Procedural Anticoagulant in Pediatrics
NCT ID: NCT00503126
Last Updated: 2011-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2007-08-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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bivalirudin
anticoagulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
16 Years
ALL
No
Sponsors
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The Medicines Company
INDUSTRY
Responsible Party
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References
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Forbes TJ, Hijazi ZM, Young G, Ringewald JM, Aquino PM, Vincent RN, Qureshi AM, Rome JJ, Rhodes JF Jr, Jones TK, Moskowitz WB, Holzer RJ, Zamora R. Pediatric catheterization laboratory anticoagulation with bivalirudin. Catheter Cardiovasc Interv. 2011 Apr 1;77(5):671-9. doi: 10.1002/ccd.22817. Epub 2011 Jan 4.
Other Identifiers
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TMC-BIV-07-01
Identifier Type: -
Identifier Source: org_study_id