Pediatric Catheter-related Thrombosis Imaging Study

Completed · Not applicable

Conditions studied: Thrombosis

In brief

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

Key facts

Study ID

NCT01137578

Run by

Bristol-Myers Squibb

People needed

151

Starts

2011-02-01

Expected to finish

2013-05-01

Last updated by the study team

2014-12-15

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arkansas Children'S Hospital — Little Rock, Arkansas, United States
• University Of Colorado Denver — Aurora, Colorado, United States
• Children'S Mercy Hospital And Clinics — Kansas City, Missouri, United States
• Akron Children'S Hospital — Akron, Ohio, United States
• Cincinnati Children'S Hospital Medical Center — Cincinnati, Ohio, United States
• The Children'S Hospital Of Philadelphia — Philadelphia, Pennsylvania, United States
• Children'S Hopsital Of Pittsburgh Of Upmc — Pittsburgh, Pennsylvania, United States
• Dodson Specialty Clinics — Fort Worth, Texas, United States
• Texas Children'S Hospital — Houston, Texas, United States
• Ut Health/Gulf States Hemophilia & Thrombophilia Ctr. — Houston, Texas, United States
• Local Institution — Buenos Aires, Buenos Aires, Argentina
• Local Institution — Buenos Aires, Buenos Aires, Argentina
• Local Institution — Buenos Aires, Buenos Aires, Argentina
• Local Institution — Vienna, Austria
• Local Institution — São Paulo, São Paulo, Brazil
• Local Institution — São Paulo, São Paulo, Brazil
• Local Institution — Edmonton, Alberta, Canada
• Local Institution — Ottawa, Ontario, Canada
• Local Institution — Toronto, Ontario, Canada
• Local Institution — Freiburg im Breisgau, Germany
• Local Institution — Hanover, Germany
• Local Institution — Guadalajara, Jalisco, Mexico
• Local Institution — Col. Secc Xvi Tlalpan, Mexico City, Mexico
• Local Institution — Monterrey, Nuevo León, Mexico
• Local Institution — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

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