Abstract
Background: Expeditiously 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 treatment for AEDH, especially for patients with brain herniation. Neurosurgeons are confronted by the decision to evacuate the hematoma with decompressive craniectomy or craniotomy. Here, we present the protocol for a randomized controlled trial targeted at comparing the outcome and economic benefits of decompressive craniectomy versus craniotomy for the treatment of traumatic brain injury (TBI) patients with cerebral herniation undergoing evacuation of AEDH.Methods/design: Patients of both genders, aged from 18 to 65 years, presenting to the emergency room with a clinical and radiological diagnosis of AEDH with herniation, comply with other inclusion and exclusion criteria are enrolled. Clinical information, including diagnosis of AEDH, clinical radiological information and treatment procedures, follow-up data of 1, 3 and 6 months post injury are collected on 120 eligible patients, randomized into groups of decompressive craniectomy versus craniotomy in a 1:1 ratio among 51 centers. The primary outcome is the Glasgow Outcome Score-Extended (GOSE) at 6 months post-injury. Secondary outcomes include incidence of post-operative cerebral infarction, incidence of additional craniocerebral surgery, and other evaluation indicator within 6 months post-injury.Discussion: This study is expected to help neurosurgeons make a better decision to evacuate the epidural hematoma with or without a DC, especially for patients with brain herniation, and improve current situation of lack of general evidence.Trial registration: Clinicaltrials.gov: NCT 04261673 (Registration date: 04 February 2020)
“It’s Only Brain Surgery”: Using 3D Printing and Simulation to Prepare Rural Physicians for the Management of Acute Epidural Hematoma