Pediatric Catheter-related Thrombosis Imaging Study



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 18
Updated:10/2/2013
Start Date:February 2011
End Date:February 2013
Contact:For participation information at a USA site use a phone number below. For site information outside the USA please email:
Email:Clinical.Trials@bms.com

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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) 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
We found this trial at
11
sites
Houston, Texas 77030
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1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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Akron, OH
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Aurora, CO
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Houston, TX
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Kansas City, Missouri 64108
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Kansas City, MO
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Little Rock, AR
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Pittsburgh, Pennsylvania 15224
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Pittsburgh, PA
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Youngstown, Ohio 44502
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Youngstown, OH
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