Abstract：
Blood levels of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase-L1 (UCH-L1) within 12h of suspected traumatic brain injury (TBI) have been approved by the Food and Drug administration to aid in determining the need for a brain computed tomography (CT) scan. The current study aimed to determine whether this context of use can be expanded beyond 12h post-TBI in patients presenting with Glasgow Coma Scale (GCS) 13-15. The prospective, 18-center Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study enrolled TBI participants aged ≥17 years who presented to a United States Level 1 trauma center and received a clinically indicated brain CT scan within 24h post-injury, a blood draw within 24h and at 14 days for biomarker analysis. Data from participants with emergency department arrival GCS 13-15 and biomarker values at days 1 and 14 were extracted for the primary analysis. A subgroup of hospitalized participants with serial biomarkers at days 1, 3, 5, and 14 were analyzed, including plasma GFAP and UCH-L1, and serum neuron-specific enolase (NSE) and S100 calcium-binding protein B (S100B). The primary analysis compared biomarker values dichotomized by head CT results (CT+/CT-). Area under receiver-operating characteristic curve (AUC) was used to determine diagnostic accuracy. The overall cohort included 1142 participants with initial GCS 13-15, with mean age 39.8 years, 65% male, and 73% Caucasian. The GFAP provided good discrimination in the overall cohort at days 1 (AUC = 0.82) and 14 (AUC = 0.72), and in the hospitalized subgroup at days 1 (AUC = 0.84), 3 (AUC = 0.88), 5 (AUC = 0.82), and 14 (AUC = 0.74). The UCH-L1, NSE, and S100B did not perform well (AUC = 0.51-0.57 across time points). This study demonstrates the utility of GFAP to aid in decision-making for diagnostic brain CT imaging beyond the 12h time frame in patients with TBI who have a GCS 13-15.
摘要：
在疑似创伤性脑损伤（TBI）的12小时（h）内，神经胶质纤维酸性蛋白（GFAP）和泛素羧基末端水解酶-L1（UCH-L1）的血液水平已获得FDA批准，以帮助确定是否需要脑计算机断层扫描（CT）扫描。当前的研究旨在确定在出现格拉斯哥昏迷量表（GCS）13-15的患者中，这种使用背景是否可以扩展到TBI后12小时以上。未来的，18个中心的转化研究和创伤性脑损伤的临床知识（TRACK-TBI）研究招募了年龄≥17岁的TBI参与者，他们到美国1级创伤中心就诊，并在受伤后24小时内接受了临床指示的脑CT扫描，在24小时内和14天内抽血进行生物标志物分析。来自急诊科到达GCS13-15的参与者的数据以及第1天和第14天的生物标志物值被提取用于主要分析。分析了在第1、3、5和14天使用系列生物标志物的住院参与者亚组，包括血浆GFAP和UCH-L1，以及血清神经元特异性烯醇化酶（NSE）和S100钙结合蛋白B（S100B）。主要分析比较了头部CT结果(CT+/CT-)二分的生物标志物值。使用接受者工作特征曲线下面积(AUC)来确定诊断准确性。整个队列包括1142名初始GCS13-15的参与者，平均年龄39.8岁，65%男性,和73%的白种人。GFAP在第1天（AUC=0.82）和第14天（AUC=0.72）的总体队列中提供了良好的区分，在第1天的住院亚组（AUC=0.84），3（AUC=0.88），5（AUC=0.82），和14(AUC=0.74)。UCH-L1,NSE,和S100B表现不佳（AUC=0.51-0.57在各个时间点）。这项研究证明了GFAP在TBI患者GCS13-15超过12h时间范围的诊断脑CT成像决策中的实用性。
