A Multicenter Trial of Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Solid Organ Injuries in Pediatric Trauma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- David Mooney
- 入组人数
- 74
- 试验地点
- 8
- 主要终点
- Proportion of Patients for Whom All Organs Identified by CT With Injuries Are Also Identified by CEUS, Regardless of Injury Grade.
研究概览
简要总结
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.
详细描述
This is an interventional 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. At conclusion of enrollment of all subjects a centralized review of CT vs. CEUS will occur to compare to real time readings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Lactating
- •CT images not available for transmission to central image repository
研究组 & 干预措施
All Study Participants
All subjects will have an abdominal non-contrast ultrasound performed. Lumason will then be administered at a dose of 0.03mL/kg up to a maximum dose of 2.4mL and a contrast-enhanced ultrasound will be performed. The dose will be given twice, for a total maximum dose per subject of 4.8mL
干预措施: Lumason (Drug)
结局指标
主要结局
Proportion of Patients for Whom All Organs Identified by CT With Injuries Are Also Identified by CEUS, Regardless of Injury Grade.
时间窗: At the time the CEUS is performed, within 48 hours of injury.
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.
次要结局
- For Each Organ, the Proportion of Patients for Whom the Organ is Identified by CT and CEUS as Injured (Regardless of Grade).(At the time the CEUS is performed, within 48 hours of injury.)
- Proportion of Injuries Identified by CEUS Which Are Within 1 Grade of the Injury Identified by CT.(At the time the CEUS is performed, within 48 hours of injury.)
- Proportion of Patients Where the Absence or Presence of Peritoneal Fluid Identified by CT is Also Identified by CEUS.(At the time the CEUS is performed, within 48 hours of injury.)
- Proportion of Patients With Agreement Between 'Real-time' and Centralized Interpretation of CEUS Images.(At the time the CEUS is performed, within 48 hours of injury.)
研究者
David Mooney
Director Trauma Program
Boston Children's Hospital