Abdominal Injury
Conditions
Keywords
Solid Organ Injury
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 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.
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 subjects will be enrolled across approximately 5 to 10 sites in the US. Each site, including the coordinating center, will undergo the training phase; each site will enroll 3 participants in this phase successfully prior to entering the treatment phase. All subjects will have had a Computerized Tomography (CT) scan as part of standard of care, confirming at least one solid organ abdominal 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 study procedures will take place within 48 hours of injury. At conclusion of enrollment of all subjects a centralized review of CT vs. CEUS will occur to compare to real-time readings.
Interventions
DRUGLumason
Lumason will be administered at a dose of 0.03 mL/kg up to a maximum dose of 2.4mL injected into a peripheral intravenous catheter. An abdominal contrast enhanced ultrasound will be performed to look for solid organ injury. The will be given twice during the intervention, for a total maximum dose per subject of 4.8mL.
Sponsors
David Mooney
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Hemodynamically stable, as determined by the trauma team 2. Age 8 through 18 years (inclusive) 3. Interpretable CT of the abdomen and pelvis that demonstrates at least one solid organ injury among the liver, spleen, pancreas, and kidneys 4. Plan for observation or admission to the hospital 5. Candidate for abdominal ultrasound based on body habitus, as determined by the investigator 6. Glasgow Coma Score of 15 7. Able to complete the study procedures within 48 hours of injury
Exclusion criteria
1. Known cardiac abnormality 2. Pulmonary Hypertension 3. Known sensitivity to any Lumason components - including sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid 4. Unable to be rolled onto side to allow lateral ultrasound windows if necessary 5. Unable to assent or consent 6. Pregnant 7. Lactating 8. CT images not available for transmission to central image repository
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall CEUS/CT Concordance for all study participants | At the time the CEUS is performed, within 48 hours of injury | A patient is classified as having a concordant assessment if each organ identified by CT with injuries is exactly identified by CEUS, regardless of injury grade, by the local study site reviewer. Otherwise, a patient is classified as having a discordant assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Organ-specific CEUS/CT Concordance | At the time the CEUS is performed, within 48 hours of injury | For each organ, a patient's organ is classified as having a concordant assessment if the presence or absence of an injury as identified by CT is exactly identified by CEUS. Otherwise, a patient is classified as having a discordant assessment. |
| Grade-specific Overall CEUS/CT Concordance | At the time the CEUS is performed, within 48 hours of injury | A patient is classified as having a concordant assessment if each organ identified by CT with injuries is exactly identified by CEUS, AND within 1 grade of the injury as identified by CT. Otherwise, a patient is classified as having a discordant assessment. |
| Peritoneal Fluid CEUS/CT Concordance | At the time the CEUS is performed, within 48 hours of injury. | A patient is classified as having a concordant assessment if the absence or presence of peritoneal fluid identified by CT is also exactly identified by CEUS. Otherwise, a patient is classified as having a discordant assessment. |
| Real-time/Centralized CEUS Concordance | At the time the CEUS is performed, within 48 hours of injury. | A patient is classified as having a concordant assessment if the absence or presence of injury for each organ identified by 'real-time' CEUS with injuries is also exactly identified by centralized interpretation of CEUS images. |
Countries
United States
Outcome results
None listed