Contrast Enhanced Ultrasound for Evaluation of Pediatric Abdominal Trauma

Abdominal Trauma Clinical Trial

Official title:

Contrast Enhanced Ultrasound for Evaluation of Pediatric Abdominal Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763840
• Other study ID #: P00004754
• Status: Completed
• Phase: Phase 1
• First received: January 4, 2013
• Last updated: January 30, 2017
• Start date: April 2013
• Est. completion date: October 2015

Study information

• Verified date: January 2017
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Injuries
• Abdominal Trauma
• Wounds and Injuries

Intervention

Drug:
• Contrast enhanced Ultrasound
Ultrasound, then contrast enhanced ultrasound.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
David Mooney

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View Citation

McCarville MB. Contrast-enhanced sonography in pediatrics. Pediatr Radiol. 2011 May;41 Suppl 1:S238-42. doi: 10.1007/s00247-011-2005-7. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome measured will be the identification of intra-abdominal injury		Baseline
Secondary	Secondary outcome will be assessment of grade of solid organ injury.		Baseline