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Pediatric Catheter-related Thrombosis Imaging Study (AESOP)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01137578
First received: June 3, 2010
Last updated: November 19, 2014
Last verified: November 2014
Results First Received: November 19, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Thrombosis
Intervention: Drug: No Intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study initiated: 28 February 2011; Study Completed: 10 May 2013. Patients with central venous catheter (CVC) in-place or planned were enrolled. The Study was diagnostic for venous thromboembolism (VTE) and was non-therapeutic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
151 participants enrolled; 134 had at least one study-related diagnostic imaging procedure completed or partially completed; 17 enrolled but not identified to a cohort and no study-related imaging procedures performed: Adverse event (2), withdrew consent (1), lost to follow up (1), poor/non-compliance (1), no longer met criteria (3), other (9).

Reporting Groups
  Description
Cohort A Cohort A included pediatric participants (full-term newborns to <18 years) in which a CVC was recently placed and who were asymptomatic for CVC-related deep vein thrombosis (DVT). Imaging procedures occurred on Day 40 ± 20 days relative to catheter placement (Day 0) and included: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used for MRI with contrast. No sedation or anesthesia was to be allowed. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.
Cohort B Cohort B included pediatric participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT based on radiographic imaging performed for other clinical reasons. Diagnostic imaging procedures, US and MRI (with and without gadolinium contrast enhancement) were to be done within 48 hours of each other or, for those with therapeutic anticoagulation, within 24 hours. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT.
Sub-Study Cohort C A Sub-study with additional cohort C was initiated to collect diagnostic imaging procedures for the detection of CVC-related DVT in a population < 18 years of age who had a CVC in place and who were scheduled to undergo a contrast enhanced MRI in any part of their body as part of their clinical care and who allowed the diagnostic imaging procedure to include the area around the CVC. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.

Participant Flow:   Overall Study
    Cohort A     Cohort B     Sub-Study Cohort C  
STARTED     77     14     43  
COMPLETED     61 [1]   12 [1]   37 [1]
NOT COMPLETED     16     2     6  
Participant requested to Discontinue                 3                 0                 0  
Withdrawal by Subject                 1                 0                 0  
Not Specified                 12                 2                 6  
[1] Completed defined as having completed all 3 study-related imaging procedures.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who completed or partially completed at least one study-related radiographic procedure.

Reporting Groups
  Description
All Imaged Participants Baseline parameters for all participants in Cohorts A, B, and C: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).

Baseline Measures
    All Imaged Participants  
Number of Participants  
[units: participants]
  134  
Age  
[units: years]
Mean ± Standard Deviation
  9.9  ± 4.89  
Age, Customized  
[units: participants]
 
Less than (<) 2 years     7  
Between 2 years and <12 years     64  
Between 12 years and <18 years     63  
Gender  
[units: participants]
 
Female     56  
Male     78  
Race/Ethnicity, Customized  
[units: participants]
 
White     117  
Black/African American     7  
Asian     3  
American Indian or Alaska native     3  
Other     4  



  Outcome Measures
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1.  Primary:   Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast   [ Time Frame: 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). ]

2.  Primary:   Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group   [ Time Frame: 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) ]

3.  Primary:   Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age   [ Time Frame: 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). ]

4.  Primary:   Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast   [ Time Frame: 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). ]

5.  Primary:   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   [ Time Frame: 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) ]

6.  Primary:   All Participants With an Adjudicated Deep Vein Thromboembolism (DVT) By Study-Related Radiographic Procedures That Diagnosed the DVT   [ Time Frame: 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) ]

7.  Secondary:   Number of All Participants Identified With Adjudicated DVT Categorized By Presence or Absence of Symptoms at Enrollment   [ Time Frame: 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) ]

8.  Secondary:   Number of Participants With Adjudicated Pulmonary Embolism (PE) Events (Symptomatic or Asymptomatic) Identified During the Study   [ Time Frame: Enrollment up to Visit 1 plus 30 days (up to approximately 90 days) ]

9.  Secondary:   Number of Deaths Which Occurred During the Study   [ Time Frame: Enrollment up to last US or MRI plus 30 days (up to approximately 90 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01137578     History of Changes
Other Study ID Numbers: CV185-077, 2009-016906-18
Study First Received: June 3, 2010
Results First Received: November 19, 2014
Last Updated: November 19, 2014
Health Authority: United States: Food and Drug Administration