Article
Author: Chen, Li-Ping ; Zheng, Xiang-Yu ; Gu, Yan-Qiu ; Zhang, Yu ; Sun, Xin ; Li, Yang ; Li, Chun-Ying ; Wang, Jing ; Liu, Xiao-Dong ; Jiang, Chun-Li ; Hu, Xue-Feng ; He, Ling ; Wang, Junmin ; Pan, De-Wang ; Zhao, Li-Li ; Nguyen, Thanh N. ; Liu, Li ; Dong, Chen-Peng ; Dong, Yang ; Jiang, Ligang ; Abuduxukuer, Reziya ; Zhang, Xian-Kun ; Wang, Cui ; Ju, Dong-Sheng ; Jiang, Yongfei ; Yang, Yi ; Cheng, Xiao-Ying ; Wang, Chun-Fei ; Guo, Zhen-Ni ; Gao, Jian-Hua ; Xin, Hong ; Liu, Xue ; Liu, Liang ; Wang, An-Ying ; Zhang, Peng ; Chen, Yu-Mei ; Qi, Ying-Bin ; Gu, Ji-Liang ; Chen, Jin-Hua ; Pang, Meng ; Jia, Yan ; Li, Song ; Qi, Shuang ; Wang, Lijuan ; Jin, Hang ; Teng, Rui-Hong ; Yuan, Zhi-Mei ; Qu, Yang ; Zhang, Ke-Jia
BACKGROUND:Currently, validated biomarkers for assessing hemorrhagic transformation (HT) after intravenous thrombolysis (IVT) are lacking. We aimed to validate a test combining GFAP (glial fibrillary acidic protein) and UCH-L1 (ubiquitin C-terminal hydrolase-L1) to indicate the absence of HT after IVT.METHODS:We prospectively enrolled consecutive patients with stroke treated with IVT from 16 hospitals. Serum GFAP and UCH-L1 levels were measured 24 hours after IVT. Cases from 1 hospital were randomly assigned to the training (70%) and testing (30%) cohorts for internal validation. The external validation cohort included patients from the other 15 hospitals. Cutoff levels of GFAP and UCH-L1 for assessing the absence of HT were established in the training cohort and subjected to internal and external verification.RESULTS:A total of 1063 patients were included. Both GFAP and UCH-L1 levels were independently associated with HT, infarct volume, and 3-month outcome; levels lower than cutoff (12.6 and 63.1 pg/mL, respectively) excluded patients with HT with a negative predictive value of 98.31% (95% CI, 89.70%–99.91%) and detection sensitivity of 98.08% (95% CI, 88.42%–99.90%) in the training cohort. In the testing and validation cohorts, negative predictive value was 100% (95% CI, 75.93%–100%) and 100% (95% CI, 82.19%–100%), respectively, and the sensitivity was 100% (95% CI, 80.76%–100%) and 100% (95% CI, 77.08%–100%), respectively.CONCLUSIONS:Serum GFAP and UCH-L1 levels exhibit high sensitivity and negative predictive value for indicating the absence of HT 24 hours after IVT, which supports their potential role in assessing patients’ condition after IVT.