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

CompletadoClinicalTrials.gov

ID: NCT01137578Tipo: INTERVENTIONALInicio: 1 de feb de 2011Fin estimado: 1 de may de 2013

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad máxima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

procedure

Ultrasound

Ultrasounds to be performed on children with central venous catheters

drug

Magnetic Resonance Imaging with Contrast

Contrast-enhanced Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters

procedure

Magnetic Resonance Imaging without Contrast

Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorPfizer

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