Pediatric Catheter-related Thrombosis Imaging Study

NCT01137578 | Completed Results DMC

• 2 other identifiers: CV185-0772009-016906-18
• Study Type: interventional
• Target: 151
• Locations: 9 countries
• Sites: 26

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

Conditions

Thrombosis

Outcome Measures

Primary Outcomes (6)

• Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast

  One set of 3 diagnostic imaging procedures (US, MRI with contrast, and MRI without contrast) was performed for all cohorts. Imaging was performed on Visit 1, which in Cohort A was Day 40 ± 20 days from Day 0, the placement of the central venous catheter (CVC), or if possible within 72 hours after a CVC was removed or lost; Visit 1 in Cohort B was within 7 days of initiation of symptoms of a CVC-related deep vein thromboembolism (DVT) or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging. Cohort C participants had an ultrasound done within 48 hours of the performance of the MRI, which was scheduled for a clinical reason. Note: participants completing each MRI procedure (with contrast or without contrast) could be different participants.

  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).

• Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group

  Imaging was performed on Visit 1 which was defined for Cohort A as: Day 40 ± 20 days from Day 0, the placement of the central venous catheter (CVC), or if possible within 72 hours after a CVC was removed or lost; Visit 1 defined for Cohort B: within 7 days of initiation of symptoms of a CVC-related deep vein thromboembolism (DVT) or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging. Cohort C participants had an ultrasound done within 48 hours of the performance of the MRI. All 3 imaging procedures, ultrasound, MRI with contrast, MRI without contrast were to be performed on all participants, regardless of the cohort.

  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)

• Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age

  One set of diagnostic imaging procedures (US and MRI) was to be performed for all cohorts The MRI consisted of MRI venous imaging without contrast enhancement and MRI venous imaging with contrast enhancement.

  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).

• Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast

  Bilateral US was attempted but if it could not be completed, a unilateral US was accepted for analysis. Participants who did not complete the MRI procedure with contrast could be different participants from those who did not complete the MRI procedure without contrast. Primary reasons for non-completion of imaging included: technical, investigator decision, child refused, parent refused, child missed appointment, difficulties with anesthesia/sedation, child unable to lie still, problems with contrast administration, and other reasons. Other reasons could include: late to appointment and unable to perform MRI due to time constraints; logistical reasons, parent agreed to only ultrasound at time of consent, schedule delay, equipment not available, difficulty putting patient in correct position. Due to the small numbers of participants in some cohorts, these data were more meaningful with all cohorts grouped together for the total imaged population.

  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).

• 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

  MRI with contrast (c) and without (w/o) contrast (c) enhancement were performed and a US was done within 48 hours of the MRI. Once detected, the DVT was adjudicated and confirmed by an independent central adjudication Committee (ICAC) consisting of experienced physicians not involved in the study and blinded to each participant's identity and clinical course. Participants were considered positive for DVT if at least one of the radiographic procedures was positive. Cohort A: Day 0=day of catheter placement; Day 40 (± 20 days)=day of imaging procedures at Visit 1, or if possible within 72 hours after a CVC is removed or lost. Cohort B Visit 1: within 7 days of initiation of symptoms of a CVC-related DVT (symptoms include but were not limited to: redness, pain/tenderness, swelling, presence of subcutaneous collaterals, catheter occlusion, and the presence of catheter related infection) or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging.

  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)

• All Participants With an Adjudicated Deep Vein Thromboembolism (DVT) By Study-Related Radiographic Procedures That Diagnosed the DVT

  Adjudication was by an Independent Central Adjudication Committee (ICAC) consisting of experienced physicians not involved in the study and blinded to each participant's identity and clinical course. One set of 3 study-related diagnostic imaging procedures (US, MRI with contrast, and MRI without contrast) was performed. Participants were considered positive for DVT if at least one of the radiographic procedures was positive.

  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 (3)

• Number of All Participants Identified With Adjudicated DVT Categorized By Presence or Absence of Symptoms at Enrollment

  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)

• Number of Participants With Adjudicated Pulmonary Embolism (PE) Events (Symptomatic or Asymptomatic) Identified During the Study

  Enrollment up to Visit 1 plus 30 days (up to approximately 90 days)

• Number of Deaths Which Occurred During the Study

  Enrollment up to last US or MRI plus 30 days (up to approximately 90 days)

Study Arms (3)

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

OTHER

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.

Procedure: Ultrasound; Drug: Magnetic Resonance Imaging with Contrast; Procedure: Magnetic Resonance Imaging without Contrast

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

OTHER

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.

Procedure: Ultrasound; Drug: Magnetic Resonance Imaging with Contrast; Procedure: Magnetic Resonance Imaging without Contrast

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

OTHER

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.

Procedure: Ultrasound; Drug: Magnetic Resonance Imaging with Contrast; Procedure: Magnetic Resonance Imaging without Contrast

Interventions

Ultrasound PROCEDURE

Ultrasounds to be performed on children with central venous catheters

Also known as: US

Cohort A: US, MRI with contrast, MRI without contrast; Cohort B: US, MRI with contrast, MRI without contrast; Cohort C: US, MRI with contrast, MRI without contrast

Magnetic Resonance Imaging with Contrast DRUG

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

Also known as: MRI with contrast

Cohort A: US, MRI with contrast, MRI without contrast; Cohort B: US, MRI with contrast, MRI without contrast; Cohort C: US, MRI with contrast, MRI without contrast

Magnetic Resonance Imaging without Contrast PROCEDURE

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

Also known as: MRI

Cohort A: US, MRI with contrast, MRI without contrast; Cohort B: US, MRI with contrast, MRI without contrast; Cohort C: US, MRI with contrast, MRI without contrast

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Pfizer: collaborator

Study Sites (26)

Arkansas Children'S Hospital

Little Rock, Arkansas, 72202, United States

Location

University Of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Children'S Mercy Hospital And Clinics

Kansas City, Missouri, 64108-4619, United States

Location

Akron Children'S Hospital

Akron, Ohio, 44308, United States

Location

Cincinnati Children'S Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

The Children'S Hospital Of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children'S Hopsital Of Pittsburgh Of Upmc

Pittsburgh, Pennsylvania, 15224, United States

Location

Dodson Specialty Clinics

Fort Worth, Texas, 76104, United States

Location

Texas Children'S Hospital

Houston, Texas, 77030, United States

Location

Ut Health/Gulf States Hemophilia & Thrombophilia Ctr.

Houston, Texas, 77030, United States

Location

Local Institution

Buenos Aires, Buenos Aires, 1270, Argentina

Location

Local Institution

Buenos Aires, Buenos Aires, 1425, Argentina

Location

Local Institution

Buenos Aires, Buenos Aires, C1181ACH, Argentina

Location

Local Institution

Vienna, A-1090, Austria

Location

Local Institution

São Paulo, São Paulo, 04023-062, Brazil

Location

Local Institution

São Paulo, São Paulo, 05410, Brazil

Location

Local Institution

Edmonton, Alberta, T6G 1C9, Canada

Location

Local Institution

Ottawa, Ontario, K1H 8L1, Canada

Location

Local Institution

Toronto, Ontario, M5G 1X8, Canada

Location

Local Institution

Freiburg im Breisgau, 79106, Germany

Location

Local Institution

Hanover, 30625, Germany

Location

Local Institution

Guadalajara, Jalisco, 44260, Mexico

Location

Local Institution

Col. Secc Xvi Tlalpan, Mexico City, 14080, Mexico

Location

Local Institution

Monterrey, Nuevo León, 64460, Mexico

Location

Local Institution

Amsterdam, 1105 AZ, Netherlands

Location

Local Institution

Glasgow, Lanarkshire, G3 8SJ, United Kingdom

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Thrombosis

Interventions

High-Energy Shock Waves; Magnetic Resonance Spectroscopy; Contrast Media

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 4, 2010
• Study Start: February 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 15, 2014
• Results First Posted: November 25, 2014

Record last verified: 2014-11

Locations

BR (2); AR (3); AU (1); ME (3); DE (2); NL (1); US (10); CA (3); GB (1)