Contrast Enhanced Ultrasound for Evaluation of Pediatric Abdominal Trauma
Completed · Phase 1
Conditions studied: Abdominal Trauma
In brief
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.
Key facts
- Study ID
- NCT01763840
- Run by
- David Mooney
- People needed
- 18
- Starts
- 2013-04-01
- Expected to finish
- 2015-10-01
- Last updated by the study team
- 2017-01-31
Who can join
Age: 2 and older, up to 35. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Boston Children's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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