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Research Question
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This protocol will serve as a pilot study to determine the validity and feasibility of
contrast enhanced magnetic resonance imaging (MRI) and/or ultrasound (US) for detection of
catheter related deep vein thrombosis (DVT) in children
(from ClinicalTrials.gov)
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Ethics Approval
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Sorry, not currently available
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Study Design
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Design Type
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Sorry, not currently available
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Design Details
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Sorry, not currently available
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Health Condition(s) or Problem
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Thrombosis
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Participants Inclusion Criteria
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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
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Participants Exclusion Criteria
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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
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Participant Sex
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Sorry, not currently available
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Participant Age Range
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Sorry, not currently available
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Participant Type
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Sorry, not currently available
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Target Sample Size
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120
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Date of First Enrolment
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Sorry, not currently available
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Date of Recruitment End
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Sorry, not currently available
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Date of End of Follow-up
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Sorry, not currently available
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Trial End Date
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Overall Trial Status
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Sorry, not currently available
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Countries of Recruitment
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United States; Argentina; Austria; Brazil; Canada; Germany; Mexico; Netherlands; United Kingdom
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Nation
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England, Scotland
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Location
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London, Glasgow
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Interventions
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Drug; No Intervention; Ultrasounds and contrast-enhanced Magnetic Resonance Imaging will be performed on children with central venous catheters; Cohort A: Asymptomatic; Cohort B: Symptomatic or incidental diagnosis; Cohort C: MRI for clinical reasons
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Primary Outcome Measures
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The number of subjects recruited into the study that are able to undergo each one of the imaging procedures (ultrasound and MRI) that are performed at Visit 1; Frequency and nature of difficulties encountered during each one of the imaging procedures (ultrasound and MRI) that are performed at visit 1; Frequency of subjects with a deep vein thrombosis (DVT) detected by the ultrasound and/or MRI at Visit 1 and confirmed by adjudication
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Secondary Outcome Measures
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Frequency of subjects in Cohort A asymptomatic for CVC-related DVT identified by the investigator at enrollment and confirmed by at least one adjudicated diagnostic imaging procedure performed at Visit 1; Visit 1 is defined for Cohort A subjects as day 40 ± 20 days from the placement of the CVC, or if possible within 72 hours after a CVC is removed or lost; No; Frequency of symptomatic subjects in Cohort B with CVC-related DVT identified by the investigator at enrollment and confirmed by at least one adjudicated diagnostic imaging procedure performed at Visit 1; Visit 1 is defined for Cohort B subjects as within 7 days of initiation of symptoms of a CVC-related DVT or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging; No; Frequency of subjects in Cohort B with or without symptoms for CVC-related DVT, incidentally identified by radiographic imaging performed for other clinical reasons as having a CVC-related DVT in the veins where the current catheter is placed; Visit 1 is defined for Cohort B subjects as within 7 days of initiation of symptoms of a CVC-related DVT or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging; No; Frequency of subjects in Cohort B with or without symptoms for CVC-related DVT, who have been incidentally identified by radiographic imaging performed for other clinical reasons as having a CVC-related DVT in the veins where the current catheter is placed, identified by the investigator at enrollment and confirmed by at least one adjudicated diagnostic imaging procedure performed at Visit 1; Frequency of asymptomatic subjects enrolled in Cohort A developing symptoms of a VTE, including DVT or Pulmonary embolism (PE), identified by the investigator between enrollment and Visit 1; The period between enrollment and Visit 1 is defined for Cohort A subjects as from the time of enrollment up to 60 days after the CVC has been placed, or from the time of enrollment up to 72 hours after the CVC is removed or lost; No; Frequency of asymptomatic subjects enrolled in Cohort A developing symptoms of a VTE, including DVT or PE, identified by the investigator between enrollment and Visit 1 and confirmed by at least one adjudicated diagnostic imaging procedure performed within 7 days of the initiation of symptoms; Frequency of adjudicated PE events (symptomatic or asymptomatic) identified during the course of the study; From enrollment up to 30 days following the study radiographic procedures (MRI and/or Ultrasound); No; Frequency of adjudicated death events occurred during the course of the study; From enrollment up to 30 days following the study radiographic procedures (MRI and/or Ultrasound); No
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Website
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http://ctr.bms.com/ctd/start.do; http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx; http://www.fda.gov/MEDWATCH/safety.htm
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