Pediatric Catheter-related Thrombosis Imaging Study

Pilot Study for Assessing Diagnostic Techniques for Central Venous Catheter-related Venous Thromboembolism

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 of catheter related deep vein thrombosis (DVT) in children

Inclusion Criteria:

• 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 Criteria:

• 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