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Contrast-Enhanced Ultrasound for Abdominal Injuries

Phase 4

Recruiting

Led By Aaron E Chen, MD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of or suspicion for blunt abdominal trauma

Hemodynamically stable (defined as not needing massive transfusion protocol and not undergoing an emergent surgical procedure within the next hour)

Must not have

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)

Known congenital or acquired heart disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, which is expected to take around 3 years

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial studied whether contrast enhanced ultrasound (CEUS) could replace CT scans in children with blunt abdominal trauma. CEUS didn't detect as many injuries as CT, so it's not ready to replace CT yet.

Who is the study for?

This trial is for children who may have internal injuries from blunt force to the belly. They must be stable enough not to need immediate surgery or a massive blood transfusion, and they should already be scheduled for or have had a CT scan. Kids with allergies to Lumason ingredients, heart disease, or penetrating abdominal wounds can't join.

What is being tested?

The study is testing if contrast-enhanced ultrasound using LUMASON can spot internal organ damage in kids with belly injuries as an alternative to CT scans. This could avoid radiation exposure and be done right at the bedside without moving the child.

What are the potential side effects?

LUMASON might cause allergic reactions in some children. Since it's used during an ultrasound, there are no radiation risks like those associated with CT scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had or might have had a blunt injury to my abdomen.

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I am not in need of an emergency blood transfusion or surgery within the next hour.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to Lumason or its components.

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I have a known heart condition from birth or acquired later.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, which is expected to take around 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, which is expected to take around 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, which is expected to take around 3 years for reporting.