Contrast Enhanced Ultrasound for Evaluation of Pediatric Abdominal Trauma
Primary Purpose
Abdominal Trauma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Contrast enhanced Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Abdominal Trauma focused on measuring Pediatric Abdominal Trauma Ultrasound Contrast
Eligibility Criteria
Inclusion Criteria:
- Hemodynamically stable
- Age 10-18 years
- Transferred to BCH Emergency Department to the Trauma Service for evaluation and management
- Concern for blunt abdominal injury
- CT A/P performed at referring institution
- Planned for admission to the hospital on the trauma service
Exclusion Criteria:
- Patients who are hemodynamically unstable
- Known cardiac abnormality
- Pulmonary hypertension
- Known sensitivity to human albumin or blood products
- Unable to roll over
- Unable to assent
- Pregnant
- Lactating
Sites / Locations
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Contrast enhanced Ultrasound
Arm Description
Presence and grade of solid organ injury on contrast enhanced ultrasound
Outcomes
Primary Outcome Measures
Primary outcome measured will be the identification of intra-abdominal injury
Secondary Outcome Measures
Secondary outcome will be assessment of grade of solid organ injury.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01763840
Brief Title
Contrast Enhanced Ultrasound for Evaluation of Pediatric Abdominal Trauma
Official Title
Contrast Enhanced Ultrasound for Evaluation of Pediatric Abdominal Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Mooney
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The research protocol aims to compare the utility of contrast enhanced abdominal sonography with computerized tomography in the evaluation of children with blunt abdominal trauma. Hemodynamically stable children ages 7-18 who are transferred to Children's Hospital on the trauma service with a CT scan of abdomen & pelvis already performed at the referring institution will be identified by the trauma service as eligible for inclusion.
The ultrasounds will be performed by one of two Attending Radiologists involved in the study. The contrast being used for the study is Optison (GE Healthcare Inc, Princeton, NJ), which is an injectable suspension of Perflutren Protein-Type A Microspheres. This has been used in echocardiography as well as abdominal ultrasonography for evaluation of pediatric abdominal and pelvic solid tumors. The contrast enhanced ultrasound will be performed by radiologist. Contrast enhancement only lasts for 3-5 minutes per injection, therefore Optison will be redosed up to 2 additional doses for the completion of the ultrasound. Vital signs will be monitored for 30 minutes after the contrast agent is given and any adverse reactions will be recorded. Adverse reactions to Optison have occurred within this time frame in the literature. Subsequent medical care will be as indicated per the clinical practice guideline.
Detailed Description
Contrast enhanced ultrasound has been used clinically in Europe for the past 10 years as an evaulation tool for examining abdominal injuries in trauma among children and adults. This is a valuable diagnostic modality that could potentially reduce the need for radiation exposure from abdominal computed tomography (CT) scans in trauma evaluation. The research protocol aims to compare the utility of contrast enhanced abdominal sonography with computerized tomography in the evaluation of children with blunt abdominal trauma. Hemodynamically stable children ages 7-18 who are transferred to Children's Hospital on the trauma service with a CT scan of abdomen & pelvis already performed at the referring institution will be identified by the trauma service as eligible for inclusion. Children who are hemodynamically unstable, known cardiac abnormality, unable to roll over, or unable to assent will be excluded from the study. If the child is enrolled in the study, he/she will have a non contrast ultrasound, followed by a contrast enhanced ultrasound performed in the Radiology Department once he/she is stabilized and evaluation is completed in the Emergency Room. The patient will have vital signs (including blood pressure, heart rate, respiratory rate, oxygen saturation) monitored during the study and 30 minutes after contrast administration.
The ultrasounds will be performed by one of two Attending Radiologists involved in the study. The contrast being used for the study is Optison (GE Healthcare Inc, Princeton, NJ), which is an injectable suspension of Perflutren Protein-Type A Microspheres. This has been used in echocardiography as well as abdominal ultrasonography for evaluation of pediatric abdominal and pelvic solid tumors. After the non contrast ultrasound is performed, the Optison contrast agent will be given via peripheral IV. The contrast enhanced ultrasound will be performed by radiologist. Contrast enhancement only lasts for 3-5 minutes per injection, therefore Optison will be redosed up to 2 additional doses for the completion of the ultrasound. Vital signs will be monitored for 30 minutes after the contrast agent is given and any adverse reactions will be recorded. Adverse reactions to Optison have occurred within this time frame in the literature. Subsequent medical care will be as indicated per the clinical practice guideline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Trauma
Keywords
Pediatric Abdominal Trauma Ultrasound Contrast
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Contrast enhanced Ultrasound
Arm Type
Experimental
Arm Description
Presence and grade of solid organ injury on contrast enhanced ultrasound
Intervention Type
Drug
Intervention Name(s)
Contrast enhanced Ultrasound
Other Intervention Name(s)
Optison
Intervention Description
Ultrasound, then contrast enhanced ultrasound.
Primary Outcome Measure Information:
Title
Primary outcome measured will be the identification of intra-abdominal injury
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Secondary outcome will be assessment of grade of solid organ injury.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hemodynamically stable
Age 10-18 years
Transferred to BCH Emergency Department to the Trauma Service for evaluation and management
Concern for blunt abdominal injury
CT A/P performed at referring institution
Planned for admission to the hospital on the trauma service
Exclusion Criteria:
Patients who are hemodynamically unstable
Known cardiac abnormality
Pulmonary hypertension
Known sensitivity to human albumin or blood products
Unable to roll over
Unable to assent
Pregnant
Lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Zalieckas, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19118722
Citation
Dolan MS, Gala SS, Dodla S, Abdelmoneim SS, Xie F, Cloutier D, Bierig M, Mulvagh SL, Porter TR, Labovitz AJ. Safety and efficacy of commercially available ultrasound contrast agents for rest and stress echocardiography a multicenter experience. J Am Coll Cardiol. 2009 Jan 6;53(1):32-8. doi: 10.1016/j.jacc.2008.08.066.
Results Reference
background
PubMed Identifier
20233859
Citation
Abdelmoneim SS, Bernier M, Scott CG, Dhoble A, Ness SA, Hagen ME, Moir S, McCully RB, Pellikka PA, Mulvagh SL. Safety of contrast agent use during stress echocardiography in patients with elevated right ventricular systolic pressure: a cohort study. Circ Cardiovasc Imaging. 2010 May;3(3):240-8. doi: 10.1161/CIRCIMAGING.109.895029. Epub 2010 Mar 16.
Results Reference
background
PubMed Identifier
21938505
Citation
Darge K; CEUS task force of the Society for Pediatric Radiology. Contrast-enhanced US (CEUS) in children: ready for prime time in the United States. Pediatr Radiol. 2011 Nov;41(11):1486-8. doi: 10.1007/s00247-011-2240-y. Epub 2011 Sep 22. No abstract available.
Results Reference
background
PubMed Identifier
21523607
Citation
McCarville MB. Contrast-enhanced sonography in pediatrics. Pediatr Radiol. 2011 May;41 Suppl 1:S238-42. doi: 10.1007/s00247-011-2005-7. Epub 2011 Apr 27.
Results Reference
background
PubMed Identifier
22249601
Citation
McCarville MB, Kaste SC, Hoffer FA, Khan RB, Walton RC, Alpert BS, Furman WL, Li C, Xiong X. Contrast-enhanced sonography of malignant pediatric abdominal and pelvic solid tumors: preliminary safety and feasibility data. Pediatr Radiol. 2012 Jul;42(7):824-33. doi: 10.1007/s00247-011-2338-2. Epub 2012 Jan 17.
Results Reference
background
PubMed Identifier
16374692
Citation
McMahon CJ, Ayres NA, Bezold LI, Lewin MB, Alonzo M, Altman CA, Kovalchin JP, Eidem BW, Pignatelli RH. Safety and efficacy of intravenous contrast imaging in pediatric echocardiography. Pediatr Cardiol. 2005 Jul-Aug;26(4):413-7. doi: 10.1007/s00246-004-0795-1.
Results Reference
background
PubMed Identifier
18195385
Citation
Valentino M, Serra C, Pavlica P, Labate AM, Lima M, Baroncini S, Barozzi L. Blunt abdominal trauma: diagnostic performance of contrast-enhanced US in children--initial experience. Radiology. 2008 Mar;246(3):903-9. doi: 10.1148/radiol.2463070652. Epub 2008 Jan 14.
Results Reference
background
PubMed Identifier
18848430
Citation
Wei K, Mulvagh SL, Carson L, Davidoff R, Gabriel R, Grimm RA, Wilson S, Fane L, Herzog CA, Zoghbi WA, Taylor R, Farrar M, Chaudhry FA, Porter TR, Irani W, Lang RM. The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. J Am Soc Echocardiogr. 2008 Nov;21(11):1202-6. doi: 10.1016/j.echo.2008.07.019. Epub 2008 Oct 10.
Results Reference
background
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Contrast Enhanced Ultrasound for Evaluation of Pediatric Abdominal Trauma
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