Biochemistry and Molecular Genetic Department, CHU Clermont-Ferrand, Université Clermont Auvergne, CNRS, INSERM, GReD, Clermont-Ferrand, France.
DRCI, CHU Clermont-Ferrand, Université Clermont-Auvergne, INSERM U1107, NEURO-DOL, Clermont-Ferrand, France.
BMJ Open. 2019 May 24;9(5):e027365. doi: 10.1136/bmjopen-2018-027365.
S100B serum analysis in clinical routine could reduce the number of cranial CT (CCT) scans performed on children with mild traumatic brain injury (mTBI). Sampling should take place within 3 hours of trauma and cut-off levels should be based on paediatric reference ranges. The aim of this study is to evaluate the utility of measuring serum S100B in the management of paediatric mTBI by demonstrating a decrease in the number of CCT scans prescribed in an S100B biomonitoring group compared with a 'conventional management' control group, with the assumption of a 30% relative decrease of the number of CCT scans between the two groups.
The protocol is a randomised, multicentre, unblinded, prospective, interventional study (nine centres) using a stepped wedge cluster design, comparing two groups (S100B biomonitoring and control). Children in the control group will have CCT scans or be hospitalised according to the current recommendations of the French Society of Paediatrics (SFP). In the S100B biomonitoring group, blood sampling to determine serum S100B protein levels will take place within 3 hours after mTBI and subsequent management will depend on the assay. If S100B is in the normal range according to age, the children will be discharged from the emergency department after 6 hours' observation. If the result is abnormal, CCT scans or hospitalisation will be prescribed in accordance with current SFP recommendations. The primary outcome measure will be the proportion of CCT scans performed (absence/presence of CCT scan for each patient) in the 48 hours following mTBI.
The protocol presented (Version 5, 03 November 2017) has been approved by the ethics committee Comité de Protection des Personnes sud-est 6 (first approval 08 June 2016, IRB: 00008526). Participation in the study is voluntary and anonymous. The study findings will be disseminated in international peer-reviewed journals and presented at relevant conferences.
NCT02819778.
在临床常规中分析 S100B 血清可以减少对患有轻度创伤性脑损伤（mTBI）的儿童进行的头颅 CT（CCT）扫描次数。采样应在创伤后 3 小时内进行，截止值应基于儿科参考范围。本研究的目的是通过证明 S100B 生物监测组中规定的 CCT 扫描数量与“常规管理”对照组相比减少，从而评估测量血清 S100B 在小儿 mTBI 管理中的效用，假设两组之间 CCT 扫描数量减少 30%。
该方案是一项随机、多中心、非盲、前瞻性、干预性研究（九个中心），采用阶梯式楔形集群设计，比较两组（S100B 生物监测和对照组）。对照组中的儿童将根据法国儿科学会（SFP）的当前建议进行 CCT 扫描或住院治疗。在 S100B 生物监测组中，在 mTBI 后 3 小时内进行血液采样以确定血清 S100B 蛋白水平，随后的管理将取决于检测结果。如果 S100B 根据年龄在正常范围内，儿童将在急诊科观察 6 小时后出院。如果结果异常，将根据当前 SFP 建议进行 CCT 扫描或住院治疗。主要观察指标为 mTBI 后 48 小时内进行的 CCT 扫描比例（每位患者的有无 CCT 扫描）。
本研究方案（第 5 版，2017 年 11 月 3 日）已获得 sud-est 6 保护委员会委员会伦理委员会的批准（首次批准日期：2016 年 6 月 8 日，IRB：00008526）。参与研究是自愿和匿名的。研究结果将在国际同行评议期刊上发表，并在相关会议上展示。
NCT02819778。
