Interventional Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,209
- 试验地点
- 22
- 主要终点
- utility of serum S100B measurement in the management of pediatric mTBI
研究概览
简要总结
Mild traumatic brain injury (mTBI) is a very common reason for presentation to pediatric emergency departments. So as not to overlook the risk of complications, which occur at a rate of 0-7%, measures such as cranial computed tomography (CCT-scan) and/or short inpatient observation are prescribed. Ultimately, the majority of these measures could be avoided and a large Australian cohort shows that the risk of brain tumors is 2.44 times higher for children who had a CCT-scan (3.24 for age 1-4 years). Assay of a sensitive biomarker in blood, such as the S100B protein, has the potential to reduce the number of these unnecessary measures.
详细描述
Based on initial results from a previous prospective study, a multicenter interventional study will be necessary to validate the routine use of this biomarker .The ultimate goal is to include serum S100B assay in the current recommendations for m traumatic brain injury (mTBI) management based on the study of Kupperman et al. (2009), as mTBI accounts for 5-8% of pediatric emergency admissions in France (60-100 per 100,000 children). The study of Kuppermann et al. strongly dictated the recommendations for mTBI management by the French Society of Emergency Medicine (SFMU) . Then, from these 2 publications, the French Society of Pediatrics (SFP) redacted their recommendations after adjustment method recommendations for clinical practice, used by the French High Authority of Health (HAS) .
The use of serum S100B assay as part of the management of pediatric mTBI should make it possible to reduce the number of additional examinations, in particular a 30% reduction in the number of CCT-scans, with a resultant reduction in radiation exposure, known to be a risk factor for cancer. The study protocol corresponds to a diagnostic prospective, controlled, multicenter study using a randomized stepped wedge cluster design, in which pediatric patients (aged ≤ 16 years) presenting to the pediatric emergency room for mTBI with a GCS score of 15 will benefit from usual care ("conventional management" arm) in the control group, and from S100B management in the interventional group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≤ 16 years Therapeutic management within 3 hours after TBI
- •GCS score of 15 classically requiring hospitalization and/or CCT-scan as per SFP recommendations (Lorton et al., 2014). These criteria are:
- •For children aged under 2 years (CCT-scan or hospitalization recommended according to physician's evaluation):
- •Parietal or occipital scalp hematoma,
- •Loss of consciousness for more than 5 seconds,
- •Trauma due to serious accident (road accident with passenger ejected from vehicle or death of another person or rollover; pedestrian hit by a moving vehicle; cyclist not wearing a helmet; fall from a height greater than 0.9 meter),
- •Abnormal behavior in the opinion of parents.
- •For children 2 years and older (CCT-scan or hospitalization recommended according to physician's evaluation):
- •Loss of consciousness at time of accident,
- •Vomiting,
- •Trauma due to serious accident (road accident with passenger ejected from vehicle or death of another person or rollover; pedestrian hit by a moving vehicle; cyclist not wearing a helmet; fall from a height greater than 1.5 meter),
- •Severe headache.
排除标准
- •Patient already enrolled in another therapeutic trial with drug administration Down syndrome Melanoma Refusal of child Refusal of parents or legal guardian Trauma more than 3 hours earlier GCS score of 13 or 14, or signs of skull fracture or lesions of the skull base (CCT-scan recommended)
- •Children with TBI not requiring hospitalization and/or CCT-scan as per SFP recommendations (Lorton et al., 2014). This group is defined by the absence of the following criteria:
- •GCS score different from 15,
- •Age < 3 months,
- •Seriousness of accident:
- •road accident with passenger ejected from vehicle or death of another person or rollover,
- •pedestrian hit by a moving vehicle,
- •cyclist not wearing a helmet.
- •of more than 0.9 m before age 2 years,
- •of more than 1.5 m after age 2 years.
- •Loss of consciousness for 5 seconds or more,
- •Inconsolable crying,
- •Agitation, drowsiness, feeling "slowed down", obnubilation,
- •Vomiting or headache,
- •Facial or cranial hematoma,
- •Otorrhea, rhinorrhea,
- •Child under 2 years old,
- •Loss of consciousness for less than 5 seconds,
- •Unusual behaviour,
- •Concern of family members
研究组 & 干预措施
Control group
The study protocol corresponds to a diagnostic prospective, controlled, multicenter study using a randomized stepped wedge cluster design, in which pediatric patients (aged ≤ 16 years) presenting to the pediatric emergency room for mTBI with a GCS score of 15 will benefit from usual care ("conventional management" arm) in the control group, and from S100B management in the interventional group
干预措施: usual care (Procedure)
interventional group
The study protocol corresponds to a diagnostic prospective, controlled, multicenter study using a randomized stepped wedge cluster design, in which pediatric patients (aged ≤ 16 years) presenting to the pediatric emergency room for mTBI with a GCS score of 15 will benefit from usual care ("conventional management" arm) in the control group, and from S100B management in the interventional group
干预措施: S100B (Procedure)
结局指标
主要结局
utility of serum S100B measurement in the management of pediatric mTBI
时间窗: at day 1
Evaluate the utility of serum S100B measurement in the management of pediatric mTBI by demonstrating a decrease in the proportion of CCT-scan prescribed in the "S100B management" intervention arm compared with the "conventional management" control arm, hypothesizing a 30% decrease in the number of CCT-scan between the intervention versus control arms.
次要结局
- utility of serum S100B measurement with respect to detection of complications(at day 1)
- utility of serum S100B measurement with respect to compliance of emergency physicians with the S100B assay(at day 1)
- utility of serum S100B measurement with respect to absence of intercurrent events at 48 hours and 3 weeks after mTBI(at 48 hours and 3 weeks after mTBI)
- utility of serum S100B measurement with respect to reduction in the time spent in the pediatric emergency room(at day 1)
- utility of serum S100B measurement with respect to reduction in the duration of hospitalization(at day 1)
- utility of serum S100B measurement with respect to reduction in radiation exposure (mSv)(at day 1)
- utility of serum S100B measurement with respect to reduction of the cost of management(at day 1)