PDF(Pubmed)
Abstract：
BACKGROUND: In light of the burden of traumatic brain injury (TBI) in children and the excessive number of unnecessary CT scans still being performed, new strategies are needed to limit their use while minimising the risk of delayed diagnosis of intracranial lesions (ICLs). Identifying children at higher risk of poor outcomes would enable them to be better monitored. The use of the blood-based brain biomarkers glial fibrillar acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase-L1 (UCH-L1) could help clinicians in this decision. The overall aim of this study is to provide new knowledge regarding GFAP and UCH-L1 in order to improve TBI management in the paediatric population.
METHODS: We will conduct a European, prospective, multicentre study, the BRAINI-2 paediatric study, in 20 centres in France, Spain and Switzerland with an inclusion period of 30 months for a total of 2880 children and adolescents included. To assess the performance of GFAP and UCH-L1 used separately and in combination to predict ICLs on CT scans (primary objective), 630 children less than 18 years of age with mild TBI, defined by a Glasgow Coma Scale score of 13-15 and with a CT scan will be recruited. To evaluate the potential of GFAP and UCH-L1 in predicting the prognosis after TBI (secondary objective), a further 1720 children with mild TBI but no CT scan as well as 130 children with moderate or severe TBI will be recruited. Finally, to establish age-specific reference values for GFAP and UCH-L1 (secondary objective), we will include 400 children and adolescents with no history of TBI.
BACKGROUND: This study has received ethics approval in all participating countries. Results from our study will be disseminated in international peer-reviewed journals. All procedures were developed in order to assure data protection and confidentiality.
BACKGROUND: NCT05413499.
METHODS: We will conduct a European, prospective, multicentre study, the BRAINI-2 paediatric study, in 20 centres in France, Spain and Switzerland with an inclusion period of 30 months for a total of 2880 children and adolescents included. To assess the performance of GFAP and UCH-L1 used separately and in combination to predict ICLs on CT scans (primary objective), 630 children less than 18 years of age with mild TBI, defined by a Glasgow Coma Scale score of 13-15 and with a CT scan will be recruited. To evaluate the potential of GFAP and UCH-L1 in predicting the prognosis after TBI (secondary objective), a further 1720 children with mild TBI but no CT scan as well as 130 children with moderate or severe TBI will be recruited. Finally, to establish age-specific reference values for GFAP and UCH-L1 (secondary objective), we will include 400 children and adolescents with no history of TBI.
BACKGROUND: This study has received ethics approval in all participating countries. Results from our study will be disseminated in international peer-reviewed journals. All procedures were developed in order to assure data protection and confidentiality.
BACKGROUND: NCT05413499.
摘要：
背景：鉴于儿童创伤性脑损伤（TBI）的负担以及仍在进行的不必要的CT扫描过多，需要新的策略来限制其使用,同时将颅内病变(ICL)延迟诊断的风险降至最低.确定结果不佳的风险较高的儿童将使他们能够得到更好的监测。使用基于血液的脑生物标志物胶质纤维酸性蛋白（GFAP）和泛素羧基末端水解酶-L1（UCH-L1）可以帮助临床医生做出这一决定。这项研究的总体目标是提供有关GFAP和UCH-L1的新知识，以改善儿科人群的TBI管理。
方法：我们将进行欧洲，prospective,多中心研究，BRAINI-2儿科研究，在法国的20个中心，西班牙和瑞士的纳入期为30个月，共纳入2880名儿童和青少年。为了评估GFAP和UCH-L1在CT扫描（主要目标）中单独和组合使用以预测ICL的性能，630名18岁以下儿童患有轻度TBI，由13-15的格拉斯哥昏迷量表定义，并进行CT扫描。评价GFAP和UCH-L1对TBI后预后的预测价值(次要目标)。另外,我们将招募1720名轻度TBI但未进行CT扫描的儿童以及130名中度或重度TBI儿童.最后,为GFAP和UCH-L1（次要目标）建立特定年龄的参考值，我们将包括400名没有TBI病史的儿童和青少年。
背景：该研究已在所有参与国家/地区获得伦理学的批准。我们的研究结果将在国际同行评审期刊上传播。所有程序都是为了确保数据保护和机密性而制定的。
背景：NCT05413499。
方法：我们将进行欧洲，prospective,多中心研究，BRAINI-2儿科研究，在法国的20个中心，西班牙和瑞士的纳入期为30个月，共纳入2880名儿童和青少年。为了评估GFAP和UCH-L1在CT扫描（主要目标）中单独和组合使用以预测ICL的性能，630名18岁以下儿童患有轻度TBI，由13-15的格拉斯哥昏迷量表定义，并进行CT扫描。评价GFAP和UCH-L1对TBI后预后的预测价值(次要目标)。另外,我们将招募1720名轻度TBI但未进行CT扫描的儿童以及130名中度或重度TBI儿童.最后,为GFAP和UCH-L1（次要目标）建立特定年龄的参考值，我们将包括400名没有TBI病史的儿童和青少年。
背景：该研究已在所有参与国家/地区获得伦理学的批准。我们的研究结果将在国际同行评审期刊上传播。所有程序都是为了确保数据保护和机密性而制定的。
背景：NCT05413499。
