Status:
COMPLETED
Pediatric Catheter-related Thrombosis Imaging Study
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Pfizer
Conditions:
Thrombosis
Eligibility:
All Genders
Up to 18 years
Phase:
NA
Brief Summary
This protocol will serve as a pilot study to determine the validity and feasibility of contrast enhanced magnetic resonance imaging (MRI) without and with contrast and/or ultrasound (US) for detection...
Eligibility Criteria
Inclusion
- Functioning central venous catheter in the upper or lower venous system
- Cohort A: Asymptomatic patients having placement of a new central venous catheter in the last 40±20 days
- Cohort B: Subjects who have experienced symptoms for a CVC-related DVT with a CVC in place or subjects who have been incidentally identified by radiographic imaging (imaging modalities to diagnose an incidental CVC-related DVT may include, but is not exclusive of Echocardiogram, CT scan, MRI, or Ultrasound) performed for other clinical reasons, as having a CVC-related DVT in the veins where the current catheter is placed
- Males and females from full-term newborns to \< 18 years
Exclusion
- For Cohort A subjects only, present therapeutic dosing of a systematic anticoagulant, systemic thromboprophylaxis or antiplatelet therapy. Local thromboprophylaxis \[flushes, low dose infusions of heparin of up to 5 u/kg/hr or locks with heparin, urokinase, t-plasminogen activator\] according to standard-of-care at the respective center will be allowed
- Patients unable to undergo contrast enhanced magnetic resonance imaging
- Renal function \< 50% of normal for age and size
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT01137578
Start Date
February 1 2011
End Date
May 1 2013
Last Update
December 15 2014
Active Locations (26)
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1
Arkansas Children'S Hospital
Little Rock, Arkansas, United States, 72202
2
University Of Colorado Denver
Aurora, Colorado, United States, 80045
3
Children'S Mercy Hospital And Clinics
Kansas City, Missouri, United States, 64108-4619
4
Akron Children'S Hospital
Akron, Ohio, United States, 44308