Effectiveness of Contrast-Enhanced Ultrasound



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:Any - 7
Updated:5/16/2018
Start Date:May 9, 2018
End Date:December 2019
Contact:Kate Henry, MD, MSCE
Email:henrym2@email.chop.edu
Phone:215-590-2351

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Clinical Effectiveness of Contrast-Enhanced Ultrasound in the Evaluation of Blunt Abdominal Trauma in Young Children

The purpose of the study is to generate pilot data describing test characteristics of
contrast enhanced ultrasound in young children with concern for abdominal trauma. The primary
objective in this study is to determine the sensitivity and specificity of contrast-enhanced
ultrasound (CEUS) compared to abdominal Computed Tomography (CT) in the detection of
abdominal solid organ injury in young children < 8 years of age with concern for blunt
abdominal trauma.

Abdominal trauma in children can be deadly, but intra-abdominal injuries can be difficult to
detect and often lack external signs of injury on physical exam. The current gold standard
imaging study is Computed Tomography (CT) with IV contrast, which is associated with
radiation exposure. Contrast-enhanced ultrasound is a radiation-free alternative to detect
abdominal injuries and has been studied primarily in adults and some older children, but
evidence to support its use in young children is needed.

This is a prospective study of children less than 8 years of age who are clinically stable
and undergoing an abdominal CT with IV contrast as part of their clinical care due to
concerns for abdominal trauma. Investigators will compare CEUS results with those obtained by
CT. Investigators will additionally include retrospective data of children who underwent both
abdominal CT and CEUS as part of clinical care.

Inclusion Criteria for study CEUS

1. Males or females < 8 years of age at time of enrollment

2. Clinically stable (defined as not undergoing an emergent surgical procedure in the
next hour)

3. Abdominal CT ordered or obtained

4. IV in place

Exclusion Criteria for study CEUS

1. Unable to obtain contrast-enhanced ultrasound within 72 hours after CT

2. History of allergic reaction to Lumason, sulfa-hexafluoride lipid microsphere
components, or other ingredients in Lumason (polyethylene glycol 4000,
distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na)
palmitic acid)

3. Known congenital or acquired heart disease

Alternative Inclusion and Exclusion Criteria for children who have undergone or are
undergoing CEUS as part of clinical care

Inclusion criteria:

1. Males or females < 8 years of age at time of CEUS.

2. Clinical Team plans to perform CT or has performed CT as part of clinical care for
abdominal trauma

3. Clinical Team plans to perform (or has performed) CEUS as part of clinical care

4. Date of CEUS after January 1, 2015

Exclusion Criteria: None
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Phone: 215-531-2514
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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