ThrombosisAESOPNCT01137578

Pediatric Catheter-related Thrombosis Imaging Study

A study testing Ultrasound, Magnetic Resonance Imaging with Contrast and Magnetic Resonance Imaging without Contrast in people with Thrombosis, run by Bristol-Myers Squibb at 26 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages Up to 18 years
Conditions the study is for: Thrombosis
What is being tested?: Ultrasound, Magnetic Resonance Imaging with Contrast and Magnetic Resonance Imaging without Contrast
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 151 participants
Where: 26 sitesin 9 countries
Study dates: Feb 2011to May 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

26 sites in 9 countries.

Country

City, postcode or hospital

26 sites in 9 countries

United States10 sites

Akron Children'S Hospital
Akron, Ohio, 44308
University Of Colorado Denver
Aurora, Colorado, 80045
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Dodson Specialty Clinics
Fort Worth, Texas, 76104
Texas Children'S Hospital
Houston, Texas, 77030
Ut Health/Gulf States Hemophilia & Thrombophilia Ctr.
Houston, Texas, 77030
Children'S Mercy Hospital And Clinics
Kansas City, Missouri, 64108-4619
Arkansas Children'S Hospital
Little Rock, Arkansas, 72202
The Children'S Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104
Children'S Hopsital Of Pittsburgh Of Upmc
Pittsburgh, Pennsylvania, 15224

Other trials in United States

Argentina3 sites

Local Institution
Buenos Aires, Buenos Aires, 1270
Local Institution
Buenos Aires, Buenos Aires, 1425
Local Institution
Buenos Aires, Buenos Aires, C1181ACH

Other trials in Argentina

Canada3 sites

Local Institution
Edmonton, Alberta, T6G 1C9
Local Institution
Ottawa, Ontario, K1H 8L1
Local Institution
Toronto, Ontario, M5G 1X8

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Mexico3 sites

Local Institution
Col. Secc Xvi Tlalpan, Mexico City, 14080
Local Institution
Guadalajara, Jalisco, 44260
Local Institution
Monterrey, Nuevo León, 64460

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Brazil2 sites

Local Institution
São Paulo, São Paulo, 04023-062
Local Institution
São Paulo, São Paulo, 05410

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Germany2 sites

Local Institution
Freiburg im Breisgau, 79106
Local Institution
Hanover, 30625

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Austria1 site

Local Institution
Vienna, A-1090

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Netherlands1 site

Local Institution
Amsterdam, 1105 AZ

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United Kingdom1 site

Local Institution
Glasgow, Lanarkshire, G3 8SJ

Other trials in United Kingdom

About this study

Official title: Pilot Study for Assessing Diagnostic Techniques for Central Venous Catheter-related Venous Thromboembolism

Conditions: Thrombosis
Being tested: Ultrasound, Magnetic Resonance Imaging with Contrast, Magnetic Resonance Imaging without Contrast
Medical subject headings: Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UltrasoundProcedure or surgery
Also called US
Ultrasounds to be performed on children with central venous catheters
Magnetic Resonance Imaging with ContrastDrug
Also called MRI with contrast
Contrast-enhanced Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters
Magnetic Resonance Imaging without ContrastProcedure or surgery
Also called MRI
Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters

Study groups in NCT01137578
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Procedure: Ultrasound; Drug: Magnetic Resonance Imaging with Contrast; Procedure: Magnetic Resonance Imaging without Contrast

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Adjudication was by an ICAC consisting of experienced physicians not involved in the study and blinded to each participant's identity and clinical course. One set of Study-related diagnostic imaging procedures (US, MRI with contrast, and MRI without contrast) was performed for all cohorts. Participants were considered positive for DVT if at least one of the radiographic procedures was positive.
Measured: 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
Signs and symptoms of PE include shortness of breath, pleuritic pain, cough, orthopnea, wheezing, and may have associated signs and symptoms of DVT. In the event a PE was detected while undergoing the study MRI or other imaging procedure required for care of an underlying condition, and the participant did not manifest any signs and/or symptoms of a PE, the event was considered an asymptomatic PE. The participant was managed and further investigated according to the investigator's standard of care. All diagnostic imaging procedures performed, such as contrast-enhanced computer tomography (CT) pulmonary angiogram, nuclear ventilation perfusion lung scan (V/Q scan), were submitted for adjudication as a suspected PE.
Measured: Enrollment up to Visit 1 plus 30 days (up to approximately 90 days)
Number of Deaths Which Occurred During the Study
Death as an endpoint in a participant with an adjudicated venous thromboembolism (DVT or PE) was summarized, regardless of the cause of the death. The VTE was adjudicated by a blinded central independent adjudication committee.
Measured: Enrollment up to last US or MRI plus 30 days (up to approximately 90 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011May 2013

First posted4 Jun 2010 (estimated)
Study startFeb 2011
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ThrombosisStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01137578
Sponsor's protocol ID: CV185-077
Other IDs: 2009-016906-18, 2009
Acronym: AESOP
Status last verified: Nov 2014
First submitted: 3 Jun 2010
Last updated: 15 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study for Assessing Diagnostic Techniques for Central Venous Catheter-related Venous Thromboembolism
ClinicalTrials.gov ID: NCT01137578
Acronym / sponsor ID: AESOP / CV185-077
Conditions: Thrombosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 151 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Feb 2011
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 4 Jun 2010 (estimated)
Results: Posted 25 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort A: US, MRI with contrast, MRI without contrast	Other	Procedure: Ultrasound, Drug: Magnetic Resonance Imaging with Contrast, Procedure: Magnetic Resonance Imaging without ContrastSubjects 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.
Cohort B: US, MRI with contrast, MRI without contrast	Other	Procedure: Ultrasound, Drug: Magnetic Resonance Imaging with Contrast, Procedure: Magnetic Resonance Imaging without ContrastSubjects 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.
Cohort C: US, MRI with contrast, MRI without contrast	Other	Procedure: Ultrasound, Drug: Magnetic Resonance Imaging with Contrast, Procedure: Magnetic Resonance Imaging without ContrastSubjects 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.

Who may qualify

Ages: Up to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
UltrasoundAlso: USUltrasounds to be performed on children with central venous catheters	Procedure or surgery	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 ContrastAlso: MRI with contrastContrast-enhanced Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters	Drug	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 ContrastAlso: MRIMagnetic Resonance Imaging (MRI) to be performed on children with central venous catheters	Procedure or surgery	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

Primary outcome

Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast
Time frame: 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).
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.
Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group
Time frame: 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)
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.
Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age
Time frame: 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).
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.
Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast
Time frame: 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).
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.
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
Time frame: 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)
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.
All Participants With an Adjudicated Deep Vein Thromboembolism (DVT) By Study-Related Radiographic Procedures That Diagnosed the DVT
Time frame: 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)
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.

3 secondary outcomes

Number of All Participants Identified With Adjudicated DVT Categorized By Presence or Absence of Symptoms at Enrollment
Time frame: 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
Time frame: Enrollment up to Visit 1 plus 30 days (up to approximately 90 days)
Number of Deaths Which Occurred During the Study
Time frame: Enrollment up to last US or MRI plus 30 days (up to approximately 90 days)

Results and safety

Results posted to the registry on 25 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A	77	61
Cohort B	14	12
Sub-Study Cohort C	43	37

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

Time frame: 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. Unit: participants

Measure	All Imaged Participants n = 134
Completed Ultrasound	133
Completed the MRI with Contrast	113
Completed the MRI without Contrast	113
Completed All 3 Imaging Procedures	110

Population analysed: The imaged population included all enrolled participants who had at least 1 study-related diagnostic imaging procedure.

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

Measure	Cohort A Newborn to <2Years n = 2	Cohort A 2Years to <12Years n = 30	Cohort A 12Years to <18Years n = 45	Cohort B Newborn to <2Years n = 1	Cohort B 2Years to <12Years n = 6	Cohort B 12Years to <18Years n = 7	Cohort C Newborn to <2Years n = 4	Cohort C 2Years to <12Years n = 28	Cohort C 12Years to <18Years n = 11
Only Ultrasound Completed	1	7	6	0	1	0	1	3	0
Only MRI with contrast Completed	0	0	0	0	0	0	0	0	0
Only MRI without contrast Completed	0	0	0	0	0	0	0	0	0
US and MRI with contrast Completed	0	1	0	0	0	0	0	1	0
US and MRI without contrast Completed	0	0	1	0	0	1	0	0	0
MRI with and without contrast Completed	0	0	0	0	0	0	0	0	1
All 3 Imaging Procedures Completed	1	22	38	1	5	6	3	24	10

Population analysed: The imaged population included all enrolled participants who had at least 1 study-related diagnostic imaging procedure.

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

Measure	Cohort A Participants <12Years of Age n = 32	Cohort A Participants 12Years to 18 Years n = 45	Cohort B Participants <12Years of Age n = 7	Cohort B Participants 12Years to 18 Years n = 7	Cohort C Participants <12Years of Age n = 32	Cohort C Participants 12Years to 18 Years n = 11
Required Sedation for MRI	0	0	1	0	17	0
Required Sedation for US	0	0	0	0	3	0

Population analysed: The imaged population included all participants who had at least 1 study-related diagnostic imaging procedure.

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

Measure	All Imaged Participants: No Ultrasound Performed n = 1	All Imaged Participants: Unilateral Ultrasound Performed n = 9	All Imaged Participants: No MRI Without Contrast Performed n = 21	All Imaged Participants: No MRI With Contrast Performed n = 21
Investigator Decision	0	4	2	1
Child Refused Procedure	0	0	2	3
Parent Refused Procedure	0	0	5	5
Difficulties with Anesthesia/Sedation	0	0	3	3
Child Unable to Lie Still	0	0	1	2
Problems with Contrast Administration	0	0	0	1
Missed Appointment	1	0	0	0
Parent or Child Refused to Continue US	0	2	0	0

Population analysed: Participants had at least 1 radiographic procedure performed but were unable to complete a either an Ultrasound (neither bilateral or unilateral, or could complete only a unilateral US) and/or unable to complete an MRI with contrast and/or unable to complete an MRI without contrast.

3 secondary outcomes are reported in the full results.

Adverse events

Group	Serious adverse events	Other adverse events	Deaths
All Imaged Participants	25 of 134 (18.7%)	15 of 134 (11.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

26 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound, Magnetic Resonance Imaging with Contrast and Magnetic Resonance Imaging without Contrast in people with Thrombosis, run by Bristol-Myers Squibb at 26 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Argentina, Canada, Mexico, Brazil and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast (time frame: 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).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01137578.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2014.