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Pediatric Catheter-related Thrombosis Imaging Study

NCT ID: NCT01137578

Last Updated: 2014-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-05-31

Brief Summary

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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) without and with contrast and/or ultrasound (US) for detection of catheter related deep vein thrombosis (DVT) in children

Detailed Description

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Conditions

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Thrombosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cohort A: US, MRI with contrast, MRI without contrast

Subjects with a central venous catheter (CVC) in place and asymptomatic for a CVC-related DVT to have an Ultrasound (US), Magnetic Resonance Imaging (MRI) with contrast and MRI without contrast performed.

Group Type OTHER

Ultrasound

Intervention Type PROCEDURE

Ultrasounds to be performed on children with central venous catheters

Magnetic Resonance Imaging with Contrast

Intervention Type DRUG

Contrast-enhanced Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters

Magnetic Resonance Imaging without Contrast

Intervention Type PROCEDURE

Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters

Cohort B: US, MRI with contrast, MRI without contrast

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 to have an Ultrasound, Magnetic Resonance Imaging (MRI) with contrast and MRI without contrast performed.

Group Type OTHER

Ultrasound

Intervention Type PROCEDURE

Ultrasounds to be performed on children with central venous catheters

Magnetic Resonance Imaging with Contrast

Intervention Type DRUG

Contrast-enhanced Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters

Magnetic Resonance Imaging without Contrast

Intervention Type PROCEDURE

Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters

Cohort C: US, MRI with contrast, MRI without contrast

Subjects with a CVC in place having an MRI for clinical reasons to have an Ultrasound, Magnetic Resonance Imaging (MRI) with contrast and MRI without contrast performed.

Group Type OTHER

Ultrasound

Intervention Type PROCEDURE

Ultrasounds to be performed on children with central venous catheters

Magnetic Resonance Imaging with Contrast

Intervention Type DRUG

Contrast-enhanced Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters

Magnetic Resonance Imaging without Contrast

Intervention Type PROCEDURE

Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters

Interventions

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Ultrasound

Ultrasounds to be performed on children with central venous catheters

Intervention Type PROCEDURE

Magnetic Resonance Imaging with Contrast

Contrast-enhanced Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters

Intervention Type DRUG

Magnetic Resonance Imaging without Contrast

Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters

Intervention Type PROCEDURE

Other Intervention Names

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US MRI with contrast MRI

Eligibility 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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Arkansas Children'S Hospital

Little Rock, Arkansas, United States

Site Status

University Of Colorado Denver

Aurora, Colorado, United States

Site Status

Children'S Mercy Hospital And Clinics

Kansas City, Missouri, United States

Site Status

Akron Children'S Hospital

Akron, Ohio, United States

Site Status

Cincinnati Children'S Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

The Children'S Hospital Of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Children'S Hopsital Of Pittsburgh Of Upmc

Pittsburgh, Pennsylvania, United States

Site Status

Dodson Specialty Clinics

Fort Worth, Texas, United States

Site Status

Texas Children'S Hospital

Houston, Texas, United States

Site Status

Ut Health/Gulf States Hemophilia & Thrombophilia Ctr.

Houston, Texas, United States

Site Status

Local Institution

Buenos Aires, Buenos Aires, Argentina

Site Status

Local Institution

Buenos Aires, Buenos Aires, Argentina

Site Status

Local Institution

Buenos Aires, Buenos Aires, Argentina

Site Status

Local Institution

Vienna, , Austria

Site Status

Local Institution

São Paulo, São Paulo, Brazil

Site Status

Local Institution

São Paulo, São Paulo, Brazil

Site Status

Local Institution

Edmonton, Alberta, Canada

Site Status

Local Institution

Ottawa, Ontario, Canada

Site Status

Local Institution

Toronto, Ontario, Canada

Site Status

Local Institution

Freiburg im Breisgau, , Germany

Site Status

Local Institution

Hanover, , Germany

Site Status

Local Institution

Guadalajara, Jalisco, Mexico

Site Status

Local Institution

Col. Secc Xvi Tlalpan, Mexico City, Mexico

Site Status

Local Institution

Monterrey, Nuevo León, Mexico

Site Status

Local Institution

Amsterdam, , Netherlands

Site Status

Local Institution

Glasgow, Lanarkshire, United Kingdom

Site Status

Countries

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United States Argentina Austria Brazil Canada Germany Mexico Netherlands United Kingdom

Related Links

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http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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2009-016906-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CV185-077

Identifier Type: -

Identifier Source: org_study_id