CEUS for Blunt Abdominal Trauma in Children

ConditionTrauma Abdomen

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age0-17

SponsorChildren's Hospital of Philadelphia

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

History of or suspicion for blunt abdominal trauma

Abdominal CT ordered or obtained

Disqualifiers

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)

Co-existing penetrating abdominal trauma

Known congenital or acquired heart disease

Trial design

Design model

Single group

Treatments tested in this trial

Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]
Drug
injection of Lumason (ultrasound contrast agent)
contrast-enhanced ultrasound
Device
ultrasound of the abdomen after injection of ultrasound contrast agent (Lumason)

Treatment groups

146 Participants

are divided into 1 treatment group

Group A: Contrast-enhanced ultrasound armExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Sensitivity of CEUS

calculation of sensitivity of CEUS for organ injury, as compared to gold standard CT

Time frame

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

Specificity of CEUS

calculation of specificity of CEUS for organ injury, as compared to gold standard CT exam

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Philadelphia

Lead sponsor

Mayo Clinic

Collaborator

Source ClinicalTrials.gov

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