Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Injuries in Children



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:8 - 17
Updated:2/6/2019
Start Date:November 1, 2017
End Date:December 2020
Contact:Yvonne Y Sheldon, BSN
Email:yvonne.sheldon@childrens.harvard.edu
Phone:617-919-1761

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A Multicenter Trial of Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Solid Organ Injuries in Pediatric Trauma

This study proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in
diagnosing abdominal solid organ injuries in pediatric patients. 146 subjects will be
enrolled across approximately 8 sites in the US. All subjects will have had a Computerized
Tomography (CT) scan as part of standard of care, confirming at least one solid organ
abdominal injury. All subjects will have an abdominal ultrasound without contrast, followed
by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and
contrast-enhanced ultrasound results will be compared to the CT scan results. The study
procedures will take place within 48 hours of injury.

This is an interventional study proposes to evaluate the accuracy of contrast-enhanced
ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. 146
subjects will be enrolled across approximately 8 sites in the US. All subjects will have had
a Computerized Tomography (CT) scan as part of standard of care, confirming at least one
solid organ abdominal injury. All subjects will have an abdominal ultrasound without
contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason.
Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results.
The study procedures will take place within 48 hours of injury. At conclusion of enrollment
of all subjects a centralized review of CT vs. CEUS will occur to compare to real time
readings.

Inclusion Criteria:

- Hemodynamically stable, as determined by the trauma team

- Age 8 through 17 years

- Interpretable CT of the abdomen and pelvis that demonstrates at least one abdominal
solid organ injury among the liver, spleen, pancreas, and kidneys

- Plan for observation or admission to the hospital

- Candidate for abdominal ultrasound based on body habitus

- Have a Glasgow Coma Score of 15

- Able to complete the study procedures within 48 hours of injury

Exclusion Criteria:

- Known cardiac abnormality

- Pulmonary hypertension

- Known sensitivity to sulfur hexafluoride, polyethylene glycol 4000,
distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium
(DPPG-Na), or palmitic acid

- Unable to roll over

- Unable to assent

- Pregnant

- Lactating

- CT images not available for transmission to central image repository
We found this trial at
6
sites
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: David Mooney, MD, MPH
Phone: 617-919-1761
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Phone: 513-636-6652
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Columbus, Ohio 43205
Phone: 614-722-3919
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Indianapolis, Indiana 45202
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2401 Gillham Road
Kansas City, Missouri 64108
Phone: 816-234-3575
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Palo Alto, California 94304
Phone: 650-723-6439
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