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CEUS for Blunt Abdominal Trauma in Children

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ClinicalTrials.gov Identifier: NCT03490929
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Aaron E. Chen, Children's Hospital of Philadelphia

Brief Summary:
Children with blunt abdominal trauma often get a CT as the first line imaging to evaluate for intra-abdominal organ injury. CT scans have some downsides with regard to radiation exposure, costs, and need for transport. Contrast enhanced ultrasonography has recently shown some promise as a way to detect intra-abdominal organ injury and may be able to replace the need for conventional CT scanning, without the need for ionizing radiation and the ability to be performed at the bedside.

Condition or disease Intervention/treatment Phase
Trauma Abdomen Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON] Device: contrast-enhanced ultrasound Phase 4

Detailed Description:

In children with abdominal trauma, computed tomography (CT) of the abdomen is considered the gold standard for the initial evaluation of solid organ injuries. The major drawbacks to CT include risks due to radiation exposure and necessity of transport of the patient. Ultrasound without contrast uses safer non-ionizing radiation and can be performed at the bedside, however it has been shown to have variable sensitivity and specificity for identifying intra-abdominal organ injury. Newer studies using contrast enhanced ultrasound (CEUS) have shown promise for improving the sensitivity and specificity of this imaging modality.

Hypothesis(es) and Aims:

Hypothesis: Contrast enhanced ultrasound (CEUS) has good sensitivity and specificity as compared to a gold standard conventional CT scan for the identification of intra-abdominal solid organ injury in hemodynamically stable children with blunt abdominal trauma. Specific Aims:

Primary Aim: To determine the test characteristics CEUS / conventional ultrasound for the detection of intra-abdominal solid organ injury, as compared to a gold standard CT scan, in hemodynamically stable children with blunt abdominal trauma

Design:

This will be a prospective cohort study to evaluate the test characteristics of contrast enhanced ultrasound (CEUS) for the detection of intra-abdominal solid organ injury in children with blunt abdominal trauma, as compared to a gold standard CT scan. Study subjects will be age 0-18 years, presenting with hemodynamically stable blunt abdominal trauma and for whom an abdominal CT scan is planned. The exclusion criteria will be a known allergy to the ultrasound contrast agent, co-existing penetrating abdominal trauma, or known congenital or acquired heart disease. Sample size calculations assume a baseline prevalence of disease in approximately 20% of patients receiving a CT scan, and target a sensitivity of at least 95% with a two-sided confidence interval precision of 8%, yielding an estimated sample size of 146 patients. The primary outcome will be calculation of sensitivity and specificity of CEUS as compared to a gold standard CT scan.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contrast Enhanced Ultrasonography for Blunt Abdominal Trauma Imaging in Children
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Contrast-enhanced ultrasound arm
contrast-enhanced ultrasound
Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]
injection of Lumason (ultrasound contrast agent)
Other Name: Lumason

Device: contrast-enhanced ultrasound
ultrasound of the abdomen after injection of ultrasound contrast agent (Lumason)
Other Name: ultrasound




Primary Outcome Measures :
  1. Test characteristics of CEUS as compared to gold standard CT [ Time Frame: through study completion, which is expected to take around 3 years ]
    calculation of sensitivity and specificity of CEUS, as compared to gold standard CT



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Hemodynamically stable (defined as not needing massive transfusion protocol and not undergoing an emergent surgical procedure within the next hour)
  2. History of or suspicion for blunt abdominal trauma
  3. Abdominal CT ordered or obtained

Exclusion Criteria:

  1. History of allergic reaction to Lumason, sulfur hexaflouride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)
  2. Co-existing penetrating abdominal trauma
  3. Known congenital or acquired heart disease

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): NCT03490929


Contacts
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Contact: Aaron E Chen, MD 2674260383 chena2@email.chop.edu
Contact: Rachel Rempell, MD 2155907041 rempellr@email.chop.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Aaron E Chen, MD    267-426-0383    CHENA2@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Aaron E Chen, MD Children's Hospital of Philadelphia

Publications:

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Responsible Party: Aaron E. Chen, Associate Professor of Clinical Pediatrics, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03490929    
Other Study ID Numbers: 18-014905
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Abdominal Injuries
Wounds and Injuries