Clinical trial NCT01137578: Pediatric Catheter-related Thrombosis Imaging Study
Official title: Pilot Study for Assessing Diagnostic Techniques for Central Venous Catheter-related Venous Thromboembolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thrombosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2010-06-04
Enrollment: 151
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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


Eligibility 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

Primary outcomes:
measure: Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast
timeFrame: 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).
measure: Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group
timeFrame: 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)
measure: Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age
timeFrame: 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).
measure: Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast
timeFrame: 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).
measure: 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
timeFrame: 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)
measure: All Participants With an Adjudicated Deep Vein Thromboembolism (DVT) By Study-Related Radiographic Procedures That Diagnosed the DVT
timeFrame: 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 outcomes:
measure: Number of All Participants Identified With Adjudicated DVT Categorized By Presence or Absence of Symptoms at Enrollment
timeFrame: 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)
measure: Number of Participants With Adjudicated Pulmonary Embolism (PE) Events (Symptomatic or Asymptomatic) Identified During the Study
timeFrame: Enrollment up to Visit 1 plus 30 days (up to approximately 90 days)
measure: Number of Deaths Which Occurred During the Study
timeFrame: Enrollment up to last US or MRI plus 30 days (up to approximately 90 days)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children'S Hospital
state: Arkansas
city: Aurora
country: United States
facility: University Of Colorado Denver
state: Colorado
city: Kansas City
country: United States
facility: Children'S Mercy Hospital And Clinics
state: Missouri
city: Akron
country: United States
facility: Akron Children'S Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children'S Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: The Children'S Hospital Of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children'S Hopsital Of Pittsburgh Of Upmc
state: Pennsylvania
city: Fort Worth
country: United States
facility: Dodson Specialty Clinics
state: Texas
city: Houston
country: United States
facility: Texas Children'S Hospital
state: Texas
city: Houston
country: United States
facility: Ut Health/Gulf States Hemophilia & Thrombophilia Ctr.
state: Texas
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Vienna
country: Austria
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Freiburg
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Col. Secc Xvi Tlalpan
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Lanarkshire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: