Status:
COMPLETED
The UNBLOCK Study: Utilization of Bivalirudin On Clots in Kids
Lead Sponsor:
Children's Hospital Los Angeles
Collaborating Sponsors:
Baylor College of Medicine
Children's Hospital Colorado
Conditions:
Deep Venous Thrombosis
Eligibility:
All Genders
6-18 years
Phase:
PHASE1
Brief Summary
Thrombosis is a significant medical complication in children with chronic diseases. The currently utilized treatments have many drawbacks which can lead to poor outcomes. More modern therapies are ava...
Detailed Description
This will be an open-label, single-arm, dose-finding, pharmacokinetic, safety and efficacy study of bivalirudin in children 6 months to 18 years of age with deep vein thrombosis. The specific aims are...
Eligibility Criteria
Inclusion
- Children \> 6 months to \< 18 years of age.
- Deep vein thrombosis demonstrated by objective testing (Duplex ultrasonography, venography, CT venography, MR venography, echocardiography). This imaging must be performed within 72 hours prior to initiation of study drug if no other anticoagulation has been started. If receiving other anticoagulation prior to start of study drug, imaging must be performed within 24 hours of study drug initiation.
- Informed consent and assent from parent/guardian/patient
Exclusion
- Treatment of present thrombus with thrombolytic agent.
- Treatment of present thrombus with another anticoagulant for more than 48 hours (low dose heparin for maintenance of venous or arterial catheter patency is allowed).
- Baseline prothrombin time (PT) which is more than 3 seconds above the upper limit of normal or baseline activated partial thromboplastin time (aPTT) which is more than 5 seconds above the upper limit of normal.
- Creatinine which is more than 20% above the upper limit of normal for age.
- Presence of a known bleeding disorder.
- Active bleeding.
- Planned invasive procedure within 3 days.
- Known pregnancy
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00812370
Start Date
September 1 2008
End Date
July 1 2013
Last Update
July 15 2016
Active Locations (6)
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1
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
2
UCD Hemophilia & Thrombosis Center
Aurora, Colorado, United States, 80045
3
Nationwide Children's Hospital
Columbus, Ohio, United States, 432005
4
The Childrens Hospital of Philidelphia
Philadelphia, Pennsylvania, United States, 19104