N/A N=134 Diagnostic

Pediatric Catheter-related Thrombosis Imaging Study

Thrombosis

Bottom Line

View on ClinicalTrials.gov: NCT01137578 ↗

Enrolled (actual)

134

Serious AEs

18.7%

Results posted

Nov 2014

Primary outcome: Primary: Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast — 133; 113; 113; 110 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ultrasound (Procedure); Magnetic Resonance Imaging with Contrast (Drug); Magnetic Resonance Imaging without Contrast (Procedure)
Age: Pediatric, Adult
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast	133; 113; 113; 110	—
PRIMARY Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group	1; 7; 6; 0; 1; 0	—
PRIMARY Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age	0; 0; 1; 0; 17; 0	—
PRIMARY Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast	0; 4; 2; 1; 0; 0	—
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	1; 2; 4; 1; 2; 5	—
PRIMARY All Participants With an Adjudicated Deep Vein Thromboembolism (DVT) By Study-Related Radiographic Procedures That Diagnosed the DVT	19; 9; 10	—
SECONDARY Number of All Participants Identified With Adjudicated DVT Categorized By Presence or Absence of Symptoms at Enrollment	8; 14	—
SECONDARY Number of Participants With Adjudicated Pulmonary Embolism (PE) Events (Symptomatic or Asymptomatic) Identified During the Study	0; 0; 0	—
SECONDARY Number of Deaths Which Occurred During the Study	0; 1; 0; 0; 0; 0	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01137578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.