Pediatric Catheter-related Thrombosis Imaging Study

NCT01137578

Last updated date
Study Location
Arkansas Children'S Hospital
Little Rock, Arkansas, 72202, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Thrombosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-18
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Pediatric Catheter-related Thrombosis Imaging Study
Official Title  ICMJE Pilot Study for Assessing Diagnostic Techniques for Central Venous Catheter-related Venous Thromboembolism
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Thrombosis
Intervention  ICMJE
  • Procedure: Ultrasound
    Ultrasounds to be performed on children with central venous catheters
    Other Name: US
  • Drug: Magnetic Resonance Imaging with Contrast
    Contrast-enhanced Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters
    Other Name: MRI with contrast
  • Procedure: Magnetic Resonance Imaging without Contrast
    Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters
    Other Name: MRI
Study Arms  ICMJE
  • Cohort A: US, MRI with contrast, MRI without contrast
    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.
    Interventions:
    • Procedure: Ultrasound
    • Drug: Magnetic Resonance Imaging with Contrast
    • Procedure: Magnetic Resonance Imaging without Contrast
  • Cohort B: US, MRI with contrast, MRI without contrast
    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.
    Interventions:
    • Procedure: Ultrasound
    • Drug: Magnetic Resonance Imaging with Contrast
    • Procedure: Magnetic Resonance Imaging without Contrast
  • Cohort C: US, MRI with contrast, MRI without contrast
    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.
    Interventions:
    • Procedure: Ultrasound
    • Drug: Magnetic Resonance Imaging with Contrast
    • Procedure: Magnetic Resonance Imaging without Contrast
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2014)
151
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2010)
120
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Austria,   Brazil,   Canada,   Germany,   Mexico,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01137578
Other Study ID Numbers  ICMJE CV185-077
2009-016906-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP