NCT03490929 CEUS for Blunt Abdominal Trauma in Children
| NCT ID | NCT03490929 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Children's Hospital of Philadelphia |
| Condition | Trauma Abdomen |
| Study Type | INTERVENTIONAL |
| Enrollment | 146 participants |
| Start Date | 2018-06-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 146 participants in total. It began in 2018-06-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Aaron E Chen, MD
PRINCIPAL INVESTIGATOR
Children's Hospital of Philadelphia
Frequently Asked Questions
Who can join the NCT03490929 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 17 Years, studying Trauma Abdomen. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03490929 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03490929 currently recruiting?
Yes, NCT03490929 is actively recruiting participants. Contact the research team at chena2@chop.edu for enrollment information.
Where is the NCT03490929 trial being conducted?
This trial is being conducted at Rochester, United States, Philadelphia, United States.
Who is sponsoring the NCT03490929 clinical trial?
NCT03490929 is sponsored by Children's Hospital of Philadelphia. The principal investigator is Aaron E Chen, MD at Children's Hospital of Philadelphia. The trial plans to enroll 146 participants.