Pediatric Catheter-related Thrombosis Imaging Study | Completed
Pediatric Catheter-related Thrombos... | Completed
Pediatric Catheter-related Thrombosis Imaging Study
AESOP
Trial Source

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Medical Conditions
  • Thrombosis
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01137578
Primary Trial ID Number

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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
Research Details
    Sorry, this information is not available
Phase
N/A
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Study Type
Interventional
Intervention
Procedure : Ultrasound, Drug : Magnetic Resonance Imaging with Contrast, Procedure : Magnetic Resonance Imaging without Contrast

Study Arm Groups : Cohort A: US, MRI with contrast, MRI without contrast, Cohort B: US, MRI with contrast, MRI without contrast, Cohort C: US, MRI with contrast, MRI without contrast, Cohort A: US, MRI with contrast, MRI without contrast, Cohort B: US, MRI with contrast, MRI without contrast, Cohort C: US, MRI with contrast, MRI without contrast, Cohort A: US, MRI with contrast, MRI without contrast, Cohort B: US, MRI with contrast, MRI without contrast, Cohort C: US, MRI with contrast, MRI without contrast

Intervention Type
See Interventions above
Primary Outcome Measures
    Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast; Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C).; Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group; Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C); Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age; Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C).; Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast; Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C).; Number of Participants With an Adjudicated Deep Vein Thrombosis (DVT) Detected By a Study-Related Ultrasound (US) and/or MRI, By Cohort and Age Group; Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C); All Participants With an Adjudicated Deep Vein Thromboembolism (DVT) By Study-Related Radiographic Procedures That Diagnosed the DVT; Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C)
Secondary Outcome Measures
    Number of All Participants Identified With Adjudicated DVT Categorized By Presence or Absence of Symptoms at Enrollment; Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C); Number of Participants With Adjudicated Pulmonary Embolism (PE) Events (Symptomatic or Asymptomatic) Identified During the Study; Enrollment up to Visit 1 plus 30 days (up to approximately 90 days); Number of Deaths Which Occurred During the Study; Enrollment up to last US or MRI plus 30 days (up to approximately 90 days)
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
N/A - 18 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
University of Glasgow
Glasgow
G3 8SJ
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Argentina, Austria, Brazil, Canada, Germany, Mexico, Netherlands, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Pilot Study for Assessing Diagnostic Techniques for Central Venous Catheter-related Venous Thromboembolism
EudraCT Number
Not available for this trial
Funder(s)
  • Pfizer
Other Study ID Numbers
CV185-077
Sponsor(s)
Bristol-Myers Squibb
Key Dates

Recruitment Start Date

Feb 2011

Recruitment End Date

May 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

03 Jun 2010

Date updated in source

25 Nov 2014