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

Health Conditions
  • Thrombosis
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
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)
Research Question
  • 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
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
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Countries of Recruitment
United States; Argentina; Austria; Brazil; Canada; Germany; Mexico; Netherlands; United Kingdom
Participant Sex
Both
Participant Age Range
N/A to 18 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
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
  • 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
Interventions
Procedure; Ultrasound; Ultrasounds to be performed on children with central venous catheters; [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]; Drug; Magnetic Resonance Imaging with Contrast; Contrast-enhanced Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters; [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]; Procedure; Magnetic Resonance Imaging without Contrast; Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters; [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]
Design Details
Sorry, this information is not available
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Results Reporting
Sorry, this information is not available
Acronym
AESOP
Scientific Title
Pilot Study for Assessing Diagnostic Techniques for Central Venous Catheter-related Venous Thromboembolism
Secondary Trial Identifying Number
2009-016906-18
Website
http://ctr.bms.com/ctd/start.do; http://www.bms.com/studyconnect/Pages/home.aspx; http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx; http://www.fda.gov/MEDWATCH/safety.htm
Study Funded By
Bristol-Myers Squibb
Funder Type
Sorry, this information is not available
Study Sponsored By
Bristol-Myers Squibb
Study Also Sponsored By
Pfizer
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

03 Jun 2010

Last Updated

25 Nov 2014

Date Record Refreshed on UKCTG

31 Jul 2015