Pediatric Catheter-related Thrombosis Imaging Study - Full Text View

Purpose

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

Condition	Intervention	Phase
Thrombosis	Drug: No Intervention	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Pilot Study for Assessing Diagnostic Techniques for Central Venous Catheter-related Venous Thromboembolism

Resource links provided by NLM:

MedlinePlus related topics: Deep Vein Thrombosis MRI Scans

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 [ Time Frame: Either at 40±20 days following the placement of the central venous catheter or within 7 days of symptoms of a venous thromboembolism or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging ] [ Designated as safety issue: No ]
- CVC - Central venous catheter
- DVT - Deep Vein Thrombosis
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
- Cohort B: 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
Frequency and nature of difficulties encountered during each one of the imaging procedures (ultrasound and MRI) that are performed at visit 1 [ Time Frame: Either at 40±20 days following the placement of the central venous catheter or within 7 days of symptoms of a venous thromboembolism or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging ] [ Designated as safety issue: No ]
Frequency of subjects with a deep vein thrombosis (DVT) detected by the ultrasound and/or MRI at Visit 1 and confirmed by adjudication [ Time Frame: Either at 40±20 days following the placement of the central venous catheter or within 7 days of symptoms of a venous thromboembolism or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 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 ] [ Designated as safety issue: 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 [ Time Frame: 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 ] [ Designated as safety issue: 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 [ Time Frame: 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 ] [ Designated as safety issue: 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 [ Time Frame: 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 ] [ Designated as safety issue: 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 [ Time Frame: From enrollment up to 30 days following the study radiographic procedures (MRI and/or Ultrasound) ] [ Designated as safety issue: No ]
Frequency of adjudicated death events occurred during the course of the study [ Time Frame: From enrollment up to 30 days following the study radiographic procedures (MRI and/or Ultrasound) ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	February 2011
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Cohort A: Asymptomatic Subjects with a CVC in place and asymptomatic for a CVC-related DVT	Drug: No Intervention Ultrasounds and contrast-enhanced Magnetic Resonance Imaging will be performed on children with central venous catheters
No Intervention: Cohort B: Symptomatic or incidental diagnosis Subjects with a CVC in place either symptomatic for a CVC-related DVT or having an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons	Drug: No Intervention Ultrasounds and contrast-enhanced Magnetic Resonance Imaging will be performed on children with central venous catheters
No Intervention: Cohort C: MRI for clinical reasons Subjects with a CVC in place having an MRI for clinical reasons	Drug: No Intervention Ultrasounds and contrast-enhanced Magnetic Resonance Imaging will be performed on children with central venous catheters

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137578

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 30 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Pfizer

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

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
Last Updated:	May 4, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Thrombosis
Venous Thromboembolism
Embolism and Thrombosis

Vascular Diseases
Cardiovascular Diseases
Thromboembolism

ClinicalTrials.gov processed this record on June 18, 2013

Pediatric Catheter-related Thrombosis Imaging Study (AESOP)