Thrombosis
Conditions
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
Interventions
PROCEDUREUltrasound
Ultrasounds to be performed on children with central venous catheters
Contrast-enhanced Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters
PROCEDUREMagnetic Resonance Imaging without Contrast
Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters
Sponsors
Pfizer
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All Participants With an Adjudicated Deep Vein Thromboembolism (DVT) By Study-Related Radiographic Procedures That Diagnosed the DVT | 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. |
| Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age | 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 | 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 | 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. |
| Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| Number of Deaths Which Occurred During the Study | Enrollment up to last US or MRI plus 30 days (up to approximately 90 days) | 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. |
| 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) | 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. |
Countries
Argentina, Austria, Brazil, Canada, Germany, Mexico, Netherlands, United Kingdom, United States
Participant flow
Recruitment details
Study initiated: 28 February 2011; Study Completed: 10 May 2013. Patients with central venous catheter (CVC) in-place or planned were enrolled. The Study was diagnostic for venous thromboembolism (VTE) and was non-therapeutic.
Pre-assignment details
151 participants enrolled; 134 had at least one study-related diagnostic imaging procedure completed or partially completed; 17 enrolled but not identified to a cohort and no study-related imaging procedures performed: Adverse event (2), withdrew consent (1), lost to follow up (1), poor/non-compliance (1), no longer met criteria (3), other (9).
Participants by arm
| Arm | Count |
|---|---|
| All Imaged Participants Baseline parameters for all participants in Cohorts A, B, and C: Pediatric participants (full-term newborns to \<18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C). | 134 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Other | 12 | 2 | 6 |
| Overall Study | Participant requested to Discontinue | 3 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | All Imaged Participants |
|---|---|
| Age, Continuous | 9.9 years STANDARD_DEVIATION 4.89 |
| Age, Customized Between 12 years and <18 years | 63 participants |
| Age, Customized Between 2 years and <12 years | 64 participants |
| Age, Customized Less than (<) 2 years | 7 participants |
| Race/Ethnicity, Customized American Indian or Alaska native | 3 participants |
| Race/Ethnicity, Customized Asian | 3 participants |
| Race/Ethnicity, Customized Black/African American | 7 participants |
| Race/Ethnicity, Customized Other | 4 participants |
| Race/Ethnicity, Customized White | 117 participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 134 |
| serious Total, serious adverse events | 25 / 134 |
Outcome results
Primary
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.
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)
Population: n=participants with an adjudicated DVT identified by a study-related adjudicated radiographic procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Imaged Participants | All Participants With an Adjudicated Deep Vein Thromboembolism (DVT) By Study-Related Radiographic Procedures That Diagnosed the DVT | Ultrasound (n=22) | 19 participants |
| All Imaged Participants | All Participants With an Adjudicated Deep Vein Thromboembolism (DVT) By Study-Related Radiographic Procedures That Diagnosed the DVT | MRI with Contrast (n=20) | 9 participants |
| All Imaged Participants | All Participants With an Adjudicated Deep Vein Thromboembolism (DVT) By Study-Related Radiographic Procedures That Diagnosed the DVT | MRI without Contrast (n=21) | 10 participants |
Primary
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.
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).
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Imaged Participants | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Parent Refused Procedure | 0 participants |
| All Imaged Participants | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Missed Appointment | 1 participants |
| All Imaged Participants | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Investigator Decision | 0 participants |
| All Imaged Participants | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Problems with Contrast Administration | 0 participants |
| All Imaged Participants | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Difficulties with Anesthesia/Sedation | 0 participants |
| All Imaged Participants | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Child Refused Procedure | 0 participants |
| All Imaged Participants | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Parent or Child Refused to Continue US | 0 participants |
| All Imaged Participants | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Child Unable to Lie Still | 0 participants |
| All Imaged Participants | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Other reasons | 0 participants |
| Cohort A 2Years to <12Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Child Unable to Lie Still | 0 participants |
| Cohort A 2Years to <12Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Missed Appointment | 0 participants |
| Cohort A 2Years to <12Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Problems with Contrast Administration | 0 participants |
| Cohort A 2Years to <12Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Child Refused Procedure | 0 participants |
| Cohort A 2Years to <12Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Investigator Decision | 4 participants |
| Cohort A 2Years to <12Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Parent Refused Procedure | 0 participants |
| Cohort A 2Years to <12Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Parent or Child Refused to Continue US | 2 participants |
| Cohort A 2Years to <12Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Difficulties with Anesthesia/Sedation | 0 participants |
| Cohort A 2Years to <12Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Other reasons | 3 participants |
| Cohort A 12Years to <18Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Difficulties with Anesthesia/Sedation | 3 participants |
| Cohort A 12Years to <18Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Investigator Decision | 2 participants |
| Cohort A 12Years to <18Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Child Refused Procedure | 2 participants |
| Cohort A 12Years to <18Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Parent Refused Procedure | 5 participants |
| Cohort A 12Years to <18Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Child Unable to Lie Still | 1 participants |
| Cohort A 12Years to <18Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Problems with Contrast Administration | 0 participants |
| Cohort A 12Years to <18Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Missed Appointment | 0 participants |
| Cohort A 12Years to <18Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Parent or Child Refused to Continue US | 0 participants |
| Cohort A 12Years to <18Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Other reasons | 8 participants |
| Cohort B Newborn to <2Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Missed Appointment | 0 participants |
| Cohort B Newborn to <2Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Difficulties with Anesthesia/Sedation | 3 participants |
| Cohort B Newborn to <2Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Parent Refused Procedure | 5 participants |
| Cohort B Newborn to <2Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Other reasons | 6 participants |
| Cohort B Newborn to <2Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Parent or Child Refused to Continue US | 0 participants |
| Cohort B Newborn to <2Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Child Refused Procedure | 3 participants |
| Cohort B Newborn to <2Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Problems with Contrast Administration | 1 participants |
| Cohort B Newborn to <2Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Child Unable to Lie Still | 2 participants |
| Cohort B Newborn to <2Years | Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast | Investigator Decision | 1 participants |
Primary
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.
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)
Population: The imaged population included all enrolled participants who had at least 1 study-related diagnostic imaging procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Imaged Participants | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | US and MRI without contrast Completed | 0 participants |
| All Imaged Participants | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | All 3 Imaging Procedures Completed | 1 participants |
| All Imaged Participants | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only MRI with contrast Completed | 0 participants |
| All Imaged Participants | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only Ultrasound Completed | 1 participants |
| All Imaged Participants | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | US and MRI with contrast Completed | 0 participants |
| All Imaged Participants | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only MRI without contrast Completed | 0 participants |
| All Imaged Participants | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | MRI with and without contrast Completed | 0 participants |
| Cohort A 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | US and MRI with contrast Completed | 1 participants |
| Cohort A 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only Ultrasound Completed | 7 participants |
| Cohort A 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | All 3 Imaging Procedures Completed | 22 participants |
| Cohort A 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only MRI with contrast Completed | 0 participants |
| Cohort A 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | MRI with and without contrast Completed | 0 participants |
| Cohort A 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only MRI without contrast Completed | 0 participants |
| Cohort A 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | US and MRI without contrast Completed | 0 participants |
| Cohort A 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | All 3 Imaging Procedures Completed | 38 participants |
| Cohort A 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | MRI with and without contrast Completed | 0 participants |
| Cohort A 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | US and MRI with contrast Completed | 0 participants |
| Cohort A 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | US and MRI without contrast Completed | 1 participants |
| Cohort A 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only MRI with contrast Completed | 0 participants |
| Cohort A 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only MRI without contrast Completed | 0 participants |
| Cohort A 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only Ultrasound Completed | 6 participants |
| Cohort B Newborn to <2Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only MRI without contrast Completed | 0 participants |
| Cohort B Newborn to <2Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | All 3 Imaging Procedures Completed | 1 participants |
| Cohort B Newborn to <2Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | US and MRI with contrast Completed | 0 participants |
| Cohort B Newborn to <2Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | MRI with and without contrast Completed | 0 participants |
| Cohort B Newborn to <2Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only Ultrasound Completed | 0 participants |
| Cohort B Newborn to <2Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | US and MRI without contrast Completed | 0 participants |
| Cohort B Newborn to <2Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only MRI with contrast Completed | 0 participants |
| Cohort B 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | US and MRI with contrast Completed | 0 participants |
| Cohort B 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only Ultrasound Completed | 1 participants |
| Cohort B 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only MRI with contrast Completed | 0 participants |
| Cohort B 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only MRI without contrast Completed | 0 participants |
| Cohort B 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | US and MRI without contrast Completed | 0 participants |
| Cohort B 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | MRI with and without contrast Completed | 0 participants |
| Cohort B 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | All 3 Imaging Procedures Completed | 5 participants |
| Cohort B 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only MRI without contrast Completed | 0 participants |
| Cohort B 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | MRI with and without contrast Completed | 0 participants |
| Cohort B 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only Ultrasound Completed | 0 participants |
| Cohort B 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | US and MRI without contrast Completed | 1 participants |
| Cohort B 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | US and MRI with contrast Completed | 0 participants |
| Cohort B 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | All 3 Imaging Procedures Completed | 6 participants |
| Cohort B 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only MRI with contrast Completed | 0 participants |
| Cohort C Newborn to <2Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | US and MRI without contrast Completed | 0 participants |
| Cohort C Newborn to <2Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | US and MRI with contrast Completed | 0 participants |
| Cohort C Newborn to <2Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | MRI with and without contrast Completed | 0 participants |
| Cohort C Newborn to <2Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | All 3 Imaging Procedures Completed | 3 participants |
| Cohort C Newborn to <2Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only MRI without contrast Completed | 0 participants |
| Cohort C Newborn to <2Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only Ultrasound Completed | 1 participants |
| Cohort C Newborn to <2Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only MRI with contrast Completed | 0 participants |
| Cohort C 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | US and MRI with contrast Completed | 1 participants |
| Cohort C 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only MRI without contrast Completed | 0 participants |
| Cohort C 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | US and MRI without contrast Completed | 0 participants |
| Cohort C 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only MRI with contrast Completed | 0 participants |
| Cohort C 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | All 3 Imaging Procedures Completed | 24 participants |
| Cohort C 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | MRI with and without contrast Completed | 0 participants |
| Cohort C 2Years to <12Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only Ultrasound Completed | 3 participants |
| Cohort C 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only Ultrasound Completed | 0 participants |
| Cohort C 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | MRI with and without contrast Completed | 1 participants |
| Cohort C 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | All 3 Imaging Procedures Completed | 10 participants |
| Cohort C 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only MRI with contrast Completed | 0 participants |
| Cohort C 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | US and MRI without contrast Completed | 0 participants |
| Cohort C 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | Only MRI without contrast Completed | 0 participants |
| Cohort C 12Years to <18Years | Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group | US and MRI with contrast Completed | 0 participants |
Primary
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.
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).
Population: The imaged population included all participants who had at least 1 study-related diagnostic imaging procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Imaged Participants | Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age | Required Sedation for MRI | 0 participants |
| All Imaged Participants | Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age | Required Sedation for US | 0 participants |
| Cohort A 2Years to <12Years | Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age | Required Sedation for MRI | 0 participants |
| Cohort A 2Years to <12Years | Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age | Required Sedation for US | 0 participants |
| Cohort A 12Years to <18Years | Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age | Required Sedation for MRI | 1 participants |
| Cohort A 12Years to <18Years | Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age | Required Sedation for US | 0 participants |
| Cohort B Newborn to <2Years | Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age | Required Sedation for MRI | 0 participants |
| Cohort B Newborn to <2Years | Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age | Required Sedation for US | 0 participants |
| Cohort B 2Years to <12Years | Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age | Required Sedation for MRI | 17 participants |
| Cohort B 2Years to <12Years | Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age | Required Sedation for US | 3 participants |
| Cohort B 12Years to <18Years | Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age | Required Sedation for MRI | 0 participants |
| Cohort B 12Years to <18Years | Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age | Required Sedation for US | 0 participants |
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
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.
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)
Population: The imaged population included all enrolled participants who had at least one study-related diagnostic imaging procedure. n=number of adjudicated images
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Imaged Participants | 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 | Diagnosis by MRI with c (n=2,30,45,1,6,6,4,28,11) | 0 participants |
| All Imaged Participants | 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 | Diagnosis by MRI w/o c (n=2,30,45,1,6,7,4,27,11) | 0 participants |
| All Imaged Participants | 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 | Diagnosis by US(n=2,30,45,1,6,7,4,28,11) | 1 participants |
| All Imaged Participants | 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 | DVTs (n=2,30,45,1,6,7,4,28,11) | 1 participants |
| Cohort A 2Years to <12Years | 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 | Diagnosis by MRI with c (n=2,30,45,1,6,6,4,28,11) | 1 participants |
| Cohort A 2Years to <12Years | 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 | Diagnosis by MRI w/o c (n=2,30,45,1,6,7,4,27,11) | 1 participants |
| Cohort A 2Years to <12Years | 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 | DVTs (n=2,30,45,1,6,7,4,28,11) | 2 participants |
| Cohort A 2Years to <12Years | 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 | Diagnosis by US(n=2,30,45,1,6,7,4,28,11) | 2 participants |
| Cohort A 12Years to <18Years | 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 | DVTs (n=2,30,45,1,6,7,4,28,11) | 4 participants |
| Cohort A 12Years to <18Years | 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 | Diagnosis by MRI with c (n=2,30,45,1,6,6,4,28,11) | 2 participants |
| Cohort A 12Years to <18Years | 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 | Diagnosis by MRI w/o c (n=2,30,45,1,6,7,4,27,11) | 2 participants |
| Cohort A 12Years to <18Years | 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 | Diagnosis by US(n=2,30,45,1,6,7,4,28,11) | 4 participants |
| Cohort B Newborn to <2Years | 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 | DVTs (n=2,30,45,1,6,7,4,28,11) | 1 participants |
| Cohort B Newborn to <2Years | 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 | Diagnosis by MRI with c (n=2,30,45,1,6,6,4,28,11) | 1 participants |
| Cohort B Newborn to <2Years | 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 | Diagnosis by US(n=2,30,45,1,6,7,4,28,11) | 1 participants |
| Cohort B Newborn to <2Years | 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 | Diagnosis by MRI w/o c (n=2,30,45,1,6,7,4,27,11) | 1 participants |
| Cohort B 2Years to <12Years | 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 | Diagnosis by MRI w/o c (n=2,30,45,1,6,7,4,27,11) | 1 participants |
| Cohort B 2Years to <12Years | 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 | Diagnosis by MRI with c (n=2,30,45,1,6,6,4,28,11) | 1 participants |
| Cohort B 2Years to <12Years | 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 | DVTs (n=2,30,45,1,6,7,4,28,11) | 2 participants |
| Cohort B 2Years to <12Years | 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 | Diagnosis by US(n=2,30,45,1,6,7,4,28,11) | 2 participants |
| Cohort B 12Years to <18Years | 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 | Diagnosis by MRI with c (n=2,30,45,1,6,6,4,28,11) | 2 participants |
| Cohort B 12Years to <18Years | 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 | DVTs (n=2,30,45,1,6,7,4,28,11) | 5 participants |
| Cohort B 12Years to <18Years | 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 | Diagnosis by MRI w/o c (n=2,30,45,1,6,7,4,27,11) | 3 participants |
| Cohort B 12Years to <18Years | 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 | Diagnosis by US(n=2,30,45,1,6,7,4,28,11) | 4 participants |
| Cohort C Newborn to <2Years | 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 | DVTs (n=2,30,45,1,6,7,4,28,11) | 0 participants |
| Cohort C Newborn to <2Years | 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 | Diagnosis by US(n=2,30,45,1,6,7,4,28,11) | 0 participants |
| Cohort C Newborn to <2Years | 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 | Diagnosis by MRI with c (n=2,30,45,1,6,6,4,28,11) | 0 participants |
| Cohort C Newborn to <2Years | 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 | Diagnosis by MRI w/o c (n=2,30,45,1,6,7,4,27,11) | 0 participants |
| Cohort C 2Years to <12Years | 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 | DVTs (n=2,30,45,1,6,7,4,28,11) | 4 participants |
| Cohort C 2Years to <12Years | 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 | Diagnosis by MRI with c (n=2,30,45,1,6,6,4,28,11) | 0 participants |
| Cohort C 2Years to <12Years | 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 | Diagnosis by MRI w/o c (n=2,30,45,1,6,7,4,27,11) | 1 participants |
| Cohort C 2Years to <12Years | 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 | Diagnosis by US(n=2,30,45,1,6,7,4,28,11) | 3 participants |
| Cohort C 12Years to <18Years | 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 | DVTs (n=2,30,45,1,6,7,4,28,11) | 3 participants |
| Cohort C 12Years to <18Years | 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 | Diagnosis by US(n=2,30,45,1,6,7,4,28,11) | 2 participants |
| Cohort C 12Years to <18Years | 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 | Diagnosis by MRI w/o c (n=2,30,45,1,6,7,4,27,11) | 1 participants |
| Cohort C 12Years to <18Years | 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 | Diagnosis by MRI with c (n=2,30,45,1,6,6,4,28,11) | 2 participants |
Primary
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.
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).
Population: The imaged population included all enrolled participants who had at least 1 study-related diagnostic imaging procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Imaged Participants | Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast | Completed Ultrasound | 133 participants |
| All Imaged Participants | Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast | Completed the MRI with Contrast | 113 participants |
| All Imaged Participants | Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast | Completed the MRI without Contrast | 113 participants |
| All Imaged Participants | Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast | Completed All 3 Imaging Procedures | 110 participants |
Secondary
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.
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)
Population: All participants who had an adjudicated DVT identified by at lest one study-related radiographic procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Imaged Participants | Number of All Participants Identified With Adjudicated DVT Categorized By Presence or Absence of Symptoms at Enrollment | Symptoms at Enrollment; Adjudicated DVT | 8 Participants |
| All Imaged Participants | Number of All Participants Identified With Adjudicated DVT Categorized By Presence or Absence of Symptoms at Enrollment | Asymptomatic at Enrollment, Adjudicated DVT | 14 Participants |
Secondary
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.
Time frame: Enrollment up to last US or MRI plus 30 days (up to approximately 90 days)
Population: The imaged population included all enrolled participants who had at least one study-related diagnostic imaging procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Imaged Participants | Number of Deaths Which Occurred During the Study | Death due to any cause | 0 participants |
| All Imaged Participants | Number of Deaths Which Occurred During the Study | Death related to study procedures | 0 participants |
| Cohort A 2Years to <12Years | Number of Deaths Which Occurred During the Study | Death due to any cause | 1 participants |
| Cohort A 2Years to <12Years | Number of Deaths Which Occurred During the Study | Death related to study procedures | 0 participants |
| Cohort A 12Years to <18Years | Number of Deaths Which Occurred During the Study | Death due to any cause | 0 participants |
| Cohort A 12Years to <18Years | Number of Deaths Which Occurred During the Study | Death related to study procedures | 0 participants |
Secondary
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.
Time frame: Enrollment up to Visit 1 plus 30 days (up to approximately 90 days)
Population: The imaged population included all enrolled participants who had at least one study-related diagnostic imaging procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Imaged Participants | Number of Participants With Adjudicated Pulmonary Embolism (PE) Events (Symptomatic or Asymptomatic) Identified During the Study | 0 participants |
| Cohort A 2Years to <12Years | Number of Participants With Adjudicated Pulmonary Embolism (PE) Events (Symptomatic or Asymptomatic) Identified During the Study | 0 participants |
| Cohort A 12Years to <18Years | Number of Participants With Adjudicated Pulmonary Embolism (PE) Events (Symptomatic or Asymptomatic) Identified During the Study | 0 participants |