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

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Thrombosis
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01137578
Primary Trial ID Number
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
This is available on the Clinicaltrials.gov website
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
Trial Location(s)
Royal Hospital for Sick Children
Glasgow
Glasgow City
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
United States, Argentina, Austria, Brazil, Canada, Germany, Mexico, Netherlands, United Kingdom
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 Assigned

03 Jun 2010

Last Updated

25 Nov 2014