Status:
COMPLETED
Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study)
Lead Sponsor:
David Mooney
Conditions:
Abdominal Injury
Eligibility:
All Genders
8-18 years
Phase:
PHASE1
PHASE2
Brief 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 stu...
Detailed Description
This is an interventional study which proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric trauma patients. Up to 130 subj...
Eligibility Criteria
Inclusion
- 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
- 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
- Unable to be rolled onto side to allow lateral ultrasound windows if necessary
- Unable to assent or consent
- Pregnant
- Lactating
- CT images not available for transmission to central image repository
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2025
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04718441
Start Date
May 10 2021
End Date
July 30 2025
Last Update
October 3 2025
Active Locations (5)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02118
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
4
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390