Abdominal Injury Clinical Trial
Official title:
A Multicenter Trial of Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Solid Organ Injuries in Pediatric Trauma
Verified date | June 2021 |
Source | Boston Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. 146 subjects will be enrolled across approximately 8 sites in the US. 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.
Status | Terminated |
Enrollment | 74 |
Est. completion date | October 7, 2019 |
Est. primary completion date | October 7, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 17 Years |
Eligibility | Inclusion Criteria: - Hemodynamically stable, as determined by the trauma team - Age 8 through 17 years - Interpretable CT of the abdomen and pelvis that demonstrates at least one abdominal 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 - Have a 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 sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid - Unable to roll over - Unable to assent - Pregnant - Lactating - CT images not available for transmission to central image repository |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Nationwide Children's | Columbus | Ohio |
United States | Riley Children's Health | Indianapolis | Indiana |
United States | Children's Mercy Kansas City | Kansas City | Missouri |
United States | Lucile Packard Children's Hospital | Palo Alto | California |
United States | Phoenix Children's Hospital | Phoenix | Arizona |
United States | Primary Children's Hospital | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
David Mooney |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Patients for Whom All Organs Identified by CT With Injuries Are Also Identified by CEUS, Regardless of Injury Grade. | During analysis, results of contrast enhanced ultrasound will be compared to results of CT scan that was performed as part of clinical care to determine if the organs identified as injured by CT were also identified as injured by CEUS. | At the time the CEUS is performed, within 48 hours of injury. | |
Secondary | For Each Organ, the Proportion of Patients for Whom the Organ is Identified by CT and CEUS as Injured (Regardless of Grade). | Results will be categorized by organ and analyzed to determine the percentage of injuries for each organ that were identified by CT that were also identified by CEUS. | At the time the CEUS is performed, within 48 hours of injury. | |
Secondary | Proportion of Injuries Identified by CEUS Which Are Within 1 Grade of the Injury Identified by CT. | The grade for the severity of the injury as determined by CEUS will be compared to the grade for the severity of the injury as determined by CT scan. | At the time the CEUS is performed, within 48 hours of injury. | |
Secondary | Proportion of Patients Where the Absence or Presence of Peritoneal Fluid Identified by CT is Also Identified by CEUS. | The presence or absence of peritoneal fluid as determined by CEUS will be compared to the presence or absence of peritoneal fluid as determined by CT scan. | At the time the CEUS is performed, within 48 hours of injury. | |
Secondary | Proportion of Patients With Agreement Between 'Real-time' and Centralized Interpretation of CEUS Images. | The contrast-enhanced ultrasounds will be re-read by a centralized reviewer and the results compared to those from the real-time reading. | At the time the CEUS is performed, within 48 hours of injury. |
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