Contrast Enhanced Ultrasound for Evaluation of Pediatric Abdominal Trauma

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01763840
First received: January 4, 2013
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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 Optison(GE Healthcare, Princeton, NJ) contrast enhanced abdominal sonography with computerized tomography in the evaluation of children with suspected blunt abdominal trauma. Hemodynamically stable children ages 10-18 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. A project clinical nurse will discuss enrollment in the study and obtain consent from the parent. 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 second Radiologist not performing the study will also provide a second read of the ultrasounds. They will not have access to the results of the CT scans that were performed prior to patient transfer, nor any other clinical data. 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 project clinical nurse will administer Optison contrast agent 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. Adverse reactions reported include transient headache, rash, vasovagal reaction, transient desaturation, anaphylaxis. After completion of the ultrasounds the patient will be transported to the surgical floor for admission to the hospital. Subsequent medical care will be as indicated per the clinical practice guideline.


Condition Intervention Phase
Abdominal Trauma
Drug: Ultrsound with (Perflutren Protein-Type A Microspheres) Injectable Suspension, USP
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Contrast Enhanced Ultrasound for Evaluation of Pediatric Abdominal Trauma

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Primary outcome measured will be the identification of intra-abdominal injury [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome will be assessment of grade of solid organ injury. [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: April 2013
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound with Contrast Drug: Ultrsound with (Perflutren Protein-Type A Microspheres) Injectable Suspension, USP
Other Name: Optison

  Eligibility

Ages Eligible for Study:   2 Years to 35 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763840

Contacts
Contact: Adam Simmons, MPH 8572184725 adam.simmons@childrens.harvard.edu

Locations
United States, Massachusetts
Boston Children's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Jill Zalieckas, MD         
Principal Investigator: Jill Zalieckas, MD         
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Jill Zalieckas, MD Children's Hospital Boston
  More Information

Publications:

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01763840     History of Changes
Other Study ID Numbers: P00004754
Study First Received: January 4, 2013
Last Updated: January 7, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Wounds and Injuries
Abdominal Injuries

ClinicalTrials.gov processed this record on July 20, 2014