CEUS for Blunt Abdominal Trauma in Children
Part of paid clinical trials in Rochester, Minnesota.
- Sponsor
- Children's Hospital of Philadelphia
- Study ID
- NCT03490929
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Trauma Abdomen
Eligibility Criteria
- Sex
- ALL
- Age
- 0 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON] — DRUGinjection of Lumason (ultrasound contrast agent)
- contrast-enhanced ultrasound — DEVICEultrasound of the abdomen after injection of ultrasound contrast agent (Lumason)
Study Details
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.
Key Dates
- Start date
- Jun 1, 2018
- Status verified
- Dec 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 146 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Contrast-enhanced ultrasound armcontrast-enhanced ultrasound
Primary Outcome Measure
Sensitivity of CEUS [ Time Frame: through study completion, which is expected to take around 3 years ]
Central Contacts
- Aaron E Chen, MD2674260383
- Rachel Rempell, MD2155907041
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55902 | |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19146 | Tobias Kummer, MD (PRINCIPAL_INVESTIGATOR) |
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