Efficacy and safety of compound porcine cerebroside and ganglioside injection (CPCGI) versus piracetam on cognition and functional outcomes for adults with traumatic brain injury: A study protocol for randomized controlled trial
Tao Liu,
Yunhu Yu,
Liang Mi,
Zhihao Zhao,
Mingqi Liu,
Jiao Wang,
Xin Wang,
Zhuang Sha,
Meng Nie,
Weiwei Jiang,
Chenrui Wu,
Jiangyuan Yuan,
Chuanxiang Lv,
Biao Zhao,
Kun Lin,
Zhanying Li,
Zhenyu Luo,
Xuanhui Liu,
Yu Qian,
Rongcai Jiang
Affiliations
Tao Liu
Department of Neurosurgery, Tianjin Neurological Institute, State Key Laboratory of Experimental Hematology, Key Laboratory of Post-Neuroinjury Neurorepair and Regeneration in Central Nervous System Tianjin & Ministry of Education, Tianjin Medical University General Hospital, Tianjin, China; The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia
Yunhu Yu
Department of Neurosurgery, Tianjin Neurological Institute, State Key Laboratory of Experimental Hematology, Key Laboratory of Post-Neuroinjury Neurorepair and Regeneration in Central Nervous System Tianjin & Ministry of Education, Tianjin Medical University General Hospital, Tianjin, China; Department of Clinical Research Center for Neurological Disease, the People's Hospital of HongHuaGang District of ZunYi, Guizhou, China
Liang Mi
Department of Neurosurgery, Tianjin Neurological Institute, State Key Laboratory of Experimental Hematology, Key Laboratory of Post-Neuroinjury Neurorepair and Regeneration in Central Nervous System Tianjin & Ministry of Education, Tianjin Medical University General Hospital, Tianjin, China
Zhihao Zhao
Department of Neurosurgery, Tianjin Neurological Institute, State Key Laboratory of Experimental Hematology, Key Laboratory of Post-Neuroinjury Neurorepair and Regeneration in Central Nervous System Tianjin & Ministry of Education, Tianjin Medical University General Hospital, Tianjin, China
Mingqi Liu
Department of Rehabilitation Medicine, Zhejiang Provincial People's Hospital, Hangzhou, China
Jiao Wang
Department of Epidemiology, College of Preventive Medicine, Third Military Medical University, Chongqing, China
Xin Wang
Department of Neurology, The First Affiliated Hospital of China Medical University, Liaoning, China
Zhuang Sha
Department of Neurosurgery, Tianjin Neurological Institute, State Key Laboratory of Experimental Hematology, Key Laboratory of Post-Neuroinjury Neurorepair and Regeneration in Central Nervous System Tianjin & Ministry of Education, Tianjin Medical University General Hospital, Tianjin, China
Meng Nie
Department of Neurosurgery, Tianjin Neurological Institute, State Key Laboratory of Experimental Hematology, Key Laboratory of Post-Neuroinjury Neurorepair and Regeneration in Central Nervous System Tianjin & Ministry of Education, Tianjin Medical University General Hospital, Tianjin, China
Weiwei Jiang
Department of Neurosurgery, Tianjin Neurological Institute, State Key Laboratory of Experimental Hematology, Key Laboratory of Post-Neuroinjury Neurorepair and Regeneration in Central Nervous System Tianjin & Ministry of Education, Tianjin Medical University General Hospital, Tianjin, China
Chenrui Wu
Department of Neurosurgery, Tianjin Neurological Institute, State Key Laboratory of Experimental Hematology, Key Laboratory of Post-Neuroinjury Neurorepair and Regeneration in Central Nervous System Tianjin & Ministry of Education, Tianjin Medical University General Hospital, Tianjin, China
Jiangyuan Yuan
Department of Neurosurgery, Tianjin Neurological Institute, State Key Laboratory of Experimental Hematology, Key Laboratory of Post-Neuroinjury Neurorepair and Regeneration in Central Nervous System Tianjin & Ministry of Education, Tianjin Medical University General Hospital, Tianjin, China
Chuanxiang Lv
Department of Neurosurgery, The First Hospital of Jilin University, Changchun, China
Biao Zhao
Department of Neurosurgery, the Second Affiliated Hospital of Bengbu Medical University, Bengbu, China
Kun Lin
Department of Neurosurgery, Fujian Provincial Hospital, Fujian, China
Zhanying Li
Department of Neurosurgery, Kailuan General Hospital, Hebei, China
Zhenyu Luo
Department of Neurosurgery, Shandong Provincial Third Hospital, Jinan, China
Xuanhui Liu
Department of Neurosurgery, Tianjin Neurological Institute, State Key Laboratory of Experimental Hematology, Key Laboratory of Post-Neuroinjury Neurorepair and Regeneration in Central Nervous System Tianjin & Ministry of Education, Tianjin Medical University General Hospital, Tianjin, China
Yu Qian
Department of Neurosurgery, Tianjin Neurological Institute, State Key Laboratory of Experimental Hematology, Key Laboratory of Post-Neuroinjury Neurorepair and Regeneration in Central Nervous System Tianjin & Ministry of Education, Tianjin Medical University General Hospital, Tianjin, China
Rongcai Jiang
Department of Neurosurgery, Tianjin Neurological Institute, State Key Laboratory of Experimental Hematology, Key Laboratory of Post-Neuroinjury Neurorepair and Regeneration in Central Nervous System Tianjin & Ministry of Education, Tianjin Medical University General Hospital, Tianjin, China; Corresponding author. Department of Neurosurgery, Tianjin Medical University General Hospital; Tianjin Neurological Institute, Key Laboratory of Post-Neuroinjury Neurorepair and Regeneration in Central Nervous System, Tianjin & Ministry of Education, 154 Anshan Road, Heping District, Tianjin, 300052, China.
Background: Traumatic brain injury (TBI) is a common neurosurgical disease in emergency rooms with poor prognosis, imposing severe burdens on patients and their families. Evidence indicates that piracetam and compound porcine cerebroside and ganglioside injection (CPCGI) can improve cognitive levels in TBI patients to enhance functional prognosis, but there is still a research gap regarding the efficacy of CPCGI. This study aims to determine the effectiveness and safety of CPCGI in improving cognitive and functional outcomes in TBI patients. Methods: This study is a multicenter, randomized, parallel-group, double-blind trial aiming to recruit 900 adult patients with mild to moderate TBI. After providing informed consent, 600 patients will be randomly assigned to the CPCGI group (20 ml/d, for 14 days), and 300 patients will be randomized to the piracetam group as a control (20 ml/d, for 14 days), followed up for 3 months after treatment. The primary outcome is the change in the Montreal Cognitive Assessment (MoCA) score from baseline after 3 months. The main secondary outcome measures include Mini-Mental State Examination (MMSE) scores, Glasgow Outcome Scale-Extended (GOS-E), and the Barthel Index at 1 and 3 months. Discussion: This multi-center clinical trial aims to provide high-quality evidence on the efficacy and safety of CPCGI in improving cognitive and functional outcomes in mild to moderate TBI patients. Trial registration: ChiCTR2000040466, date of registration: November 28, 2020.
