Using ultrasound with contrast to assess abdominal injuries in children
Contrast Enhanced Ultrasonography for Blunt Abdominal Trauma Imaging in Children
This study is testing if a special type of ultrasound can help find abdominal injuries in children with blunt trauma, instead of using a CT scan, to see if it’s a safer option.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 0 Years to 17 Years |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Rochester, Minnesota and 1 other locations) |
| Trial ID | NCT03490929 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of contrast enhanced ultrasound (CEUS) in detecting intra-abdominal organ injuries in children with blunt abdominal trauma, comparing its results to the conventional CT scan, which is currently the gold standard. The study aims to determine the sensitivity and specificity of CEUS, which could potentially reduce the need for CT scans, thereby minimizing radiation exposure and allowing for bedside evaluation. Participants will include hemodynamically stable children aged 0-18 years who have a history of or suspicion for blunt abdominal trauma and have an abdominal CT ordered. The study will utilize sulfur hexafluoride lipid microspheres as a contrast agent for the ultrasound procedure.
Who should consider this trial
Good fit: Ideal candidates are hemodynamically stable children aged 0-18 years with suspected blunt abdominal trauma.
Not a fit: Patients with a history of allergic reactions to the contrast agent or those with penetrating abdominal trauma may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer, radiation-free imaging alternative for children with abdominal trauma.
How similar studies have performed: Other studies have shown promise for contrast enhanced ultrasound in similar contexts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota and 1 other locations
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Aaron E Chen, MD — Children's Hospital of Philadelphia
- Study coordinator: Aaron E Chen, MD
- Email: chena2@chop.edu
- Phone: 2674260383
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.