Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study)
United States68 participantsStarted 2021-05-10
Plain-language summary
This multicenter study aims to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. Up to 130 subjects will complete the study across approximately 5-10 sites in the US, with up to 30 patients in the training phase (3 per site) and 100 patients in the treatment phase of the study. All subjects will have had a CT scan as part of standard of care, confirming at least one solid organ abdominal injury. The study procedure will occur within 48 hours from time of injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The CT and ultrasound scans will be read locally and will undergo central review.
Who can participate
Age range8 Years – 18 Years
SexALL
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Inclusion criteria
✓. Hemodynamically stable, as determined by the trauma team
✓. Age 8 through 18 years (inclusive)
✓. Interpretable CT of the abdomen and pelvis that demonstrates at least one solid organ injury among the liver, spleen, pancreas, and kidneys
✓. Plan for observation or admission to the hospital
✓. Candidate for abdominal ultrasound based on body habitus, as determined by the investigator
✓. Glasgow Coma Score of 15
✓. Able to complete the study procedures within 48 hours of injury
Exclusion criteria
✕. Known cardiac abnormality
✕. Pulmonary Hypertension
✕. Known sensitivity to any Lumason components - including sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid
What they're measuring
1
Overall CEUS/CT Concordance for all study participants
Timeframe: At the time the CEUS is performed, within 48 hours of injury