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Contrast Enhanced Ultrasound for Evaluation of Pediatric Abdominal Trauma

NCT01763840 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-01-31

No results posted yet for this study

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.

Conditions

  • Abdominal Trauma

Interventions

DRUG

Contrast enhanced Ultrasound

Ultrasound, then contrast enhanced ultrasound.

Sponsors & Collaborators

  • David Mooney

    lead OTHER

Principal Investigators

  • Jill Zalieckas, MD · Boston Children's Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01763840 on ClinicalTrials.gov