Yang Chun, Huang Xianjian, Feng Junfeng, Xie Li, Hui Jiyuan, Li Weiping, Jiang Jiyao
Brain Injury Center, Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, 160 Pujian Road, Shanghai, People's Republic of China.
Shanghai Institute of Head Trauma, Shanghai, People's Republic of China.
Trials. 2021 Jun 29;22(1):421. doi: 10.1186/s13063-021-05359-6.
The expeditious surgical evacuation of acute epidural hematoma (AEDH) is an attainable gold standard and is often expected to have a good clinical outcome for patients with surgical indications. However, controversy exists on the optimal surgical options for AEDH, especially for patients with brain herniation. Neurosurgeons are confronted with the decision to evacuate the hematoma with decompressive craniectomy (DC) or craniotomy.
METHODS/DESIGN: Patients of both sexes, age between 18 and 65 years, who presented to the emergency room with a clinical and radiological diagnosis of AEDH with herniation, were assessed against the inclusion and exclusion criteria to be enrolled in the study. Clinical and radiological information, including diagnosis of AEDH, treatment procedures, and follow-up data at 1, 3, and 6 months after injury, was collected from 120 eligible patients in 51 centers. The patients were randomized into groups of DC versus craniotomy in a 1:1 ratio. The primary outcome was the Glasgow Outcome Score-Extended (GOSE) at 6 months post-injury. Secondary outcomes included incidence of postoperative cerebral infarction, incidence of additional craniocerebral surgery, and other evaluation indicators within 6 months post-injury.
This study is expected to support neurosurgeons in their decision to evacuate the epidural hematoma with or without a DC, especially in patients with brain herniation, and provide additional evidence to improve the knowledge in clinical practice.
ClinicalTrials.gov NCT04261673 . Registered on 04 February 2020.
急性硬膜外血肿（AEDH）的快速手术清除是一个可实现的金标准，对于有手术指征的患者，通常预期会有良好的临床结果。然而，对于AEDH的最佳手术选择存在争议，尤其是对于有脑疝的患者。神经外科医生面临着采用减压性颅骨切除术（DC）或开颅手术清除血肿的决策。
方法/设计：纳入年龄在18至65岁之间、因临床和影像学诊断为AEDH并伴有脑疝而就诊于急诊室的患者，根据纳入和排除标准进行评估以纳入研究。从51个中心的120名符合条件的患者中收集临床和影像学信息，包括AEDH的诊断、治疗程序以及受伤后1个月、3个月和6个月的随访数据。患者按1:1的比例随机分为DC组和开颅手术组。主要结局是受伤后6个月的格拉斯哥扩展预后评分（GOSE）。次要结局包括术后脑梗死的发生率、额外颅脑手术的发生率以及受伤后6个月内的其他评估指标。
本研究有望支持神经外科医生决定是否采用DC清除硬膜外血肿，特别是对于有脑疝的患者，并提供更多证据以增进临床实践中的知识。
ClinicalTrials.gov NCT04261673。于2020年2月4日注册。
