Abstract
BackgroundThe 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/designPatients 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.DiscussionThis 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.Trial registrationClinicalTrials.govNCT 04261673. Registered on 04 February 2020
Highlights
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
This study is expected to support neurosurgeons in their decision to evacuate the epidural hematoma with or without a decompressive craniectomy (DC), especially in patients with brain herniation, and provide additional evidence to improve the knowledge in clinical practice
The study outcomes will possibly clarify the best indications in case of decompressive craniectomy and will support the decision-making during preoperative surgical planning in Acute epidural hematoma (AEDH) cases
Summary
AEDH patients with brain herniation [10, 11]. Two different treatment methods, decompressive craniectomy and craniotomy, will be compared, assessing the discriminative option of removing or replacing the bone flap. Neurosurgeons are confronted with the decision to evacuate the hematoma with or without a DC, especially in patients with brain herniation [6, 14]. Evidence is showing that a set of patients experienced clinical deterioration after the initial hematoma-evacuation craniotomy, as a result of secondary brain injuries with increased ICP [10, 15,16,17,18]. No consensus has been reached around the opportunity to proceed with decompressive craniectomy in the management of AEDH with brain herniation. This study is expected to help neurosurgeons in their decisions to evacuate the epidural hematoma with or without a DC, especially with cases of brain herniation, and to provide a strong level of evidence for the surgical management of AEDH.
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