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Contrast Enhanced Ultrasound for Evaluation of Pediatric Abdominal Trauma

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ClinicalTrials.gov Identifier: NCT01763840
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Abdominal Trauma Drug: Contrast enhanced Ultrasound Phase 1

Detailed 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contrast Enhanced Ultrasound for Evaluation of Pediatric Abdominal Trauma
Study Start Date : April 2013
Primary Completion Date : October 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Contrast enhanced Ultrasound
Presence and grade of solid organ injury on contrast enhanced ultrasound
Drug: Contrast enhanced Ultrasound
Ultrasound, then contrast enhanced ultrasound.
Other Name: Optison


Outcome Measures

Primary Outcome Measures :
  1. Primary outcome measured will be the identification of intra-abdominal injury [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Secondary outcome will be assessment of grade of solid organ injury. [ Time Frame: Baseline ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763840


Locations
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
David Mooney
Investigators
Principal Investigator: Jill Zalieckas, MD Boston Children’s Hospital
More Information

Publications:

Responsible Party: David Mooney, Associate Professor of Surgery, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT01763840     History of Changes
Other Study ID Numbers: P00004754
First Posted: January 9, 2013    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

Keywords provided by David Mooney, Boston Children's Hospital:
Pediatric Abdominal Trauma Ultrasound Contrast

Additional relevant MeSH terms:
Wounds and Injuries
Abdominal Injuries