Pediatric Catheter-related Thrombosis Imaging Study (AESOP)

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Thrombosis

Treatments: Procedure: Ultrasound; Procedure: Magnetic Resonance Imaging without Contrast; Drug: Magnetic Resonance Imaging with Contrast

Study type: Interventional

Funder types: Industry

Identifiers

NCT01137578

2009-016906-18 (EudraCT Number)

CV185-077

Details and patient eligibility

About

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

Enrollment: 151 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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151 participants in 3 patient groups

Cohort A: US, MRI with contrast, MRI without contrast

Other group

Description:

Subjects with a central venous catheter (CVC) in place and asymptomatic for a CVC-related DVT to have an Ultrasound (US), Magnetic Resonance Imaging (MRI) with contrast and MRI without contrast performed.

Treatment:

Procedure: Magnetic Resonance Imaging without Contrast

Drug: Magnetic Resonance Imaging with Contrast

Procedure: Ultrasound

Cohort B: US, MRI with contrast, MRI without contrast

Other group

Description:

Subjects with a CVC in place either symptomatic for a CVC-related DVT or having an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons to have an Ultrasound, Magnetic Resonance Imaging (MRI) with contrast and MRI without contrast performed.

Treatment:

Procedure: Magnetic Resonance Imaging without Contrast

Drug: Magnetic Resonance Imaging with Contrast

Procedure: Ultrasound

Cohort C: US, MRI with contrast, MRI without contrast

Other group

Description:

Subjects with a CVC in place having an MRI for clinical reasons to have an Ultrasound, Magnetic Resonance Imaging (MRI) with contrast and MRI without contrast performed.

Treatment:

Procedure: Magnetic Resonance Imaging without Contrast

Drug: Magnetic Resonance Imaging with Contrast

Procedure: Ultrasound