Decompressive craniectomy has been reported for the treatment of patients with aneurysmal subarachnoid hemorrhage (aSAH). But no prospective randomised controlled trials have yet been undertaken to confirm its effect.The purpose of the study is to determine whether decompressive craniectomy combine aneurysm clipping surgery or endovascular coiling will improve clinical outcomes of poor-grade aSAH patients.
Aneurysmal subarachnoid hemorrhage (aSAH) is a worldwide health burden with high fatality and permanent disability rates. Decompressive craniectomy, which is beneficial in patients with malignant middle cerebral artery infarction, may indirectly relieve the mass effect, decrease perihematomal tissue pressure, improve blood flow, reduce secondary brain damage and improve outcome without further damage to the brain due to surgery. Early therapy with either surgical clipping or neuroradiologic intervention with endovascular coiling is the primary treatment for aSAH. But whether decompressive craniectomy should be employed during the clipping surgery or immediately after coil embolization still have considerable controversy. 80 patients will be recruited to the trial over 12 months. Follow-up will take 6 months with analysis and reporting taking 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Decompressive craniectomy: All patients in the treatment group will receive decompressive craniectomy of at least 12 cm according to institutional guidelines and a published surgical protocol during the clipping surgery within 48 hours form the onset.
Best medical treatment: Best medical treatment is based on American Heart Association/American Stroke Association (AHA/ASA) and European Stroke Organisation (ESO) as published in the current protocol from 2012 and 2013 respectively.
Tandu Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
RECRUITINGModified Rankin scale (mRS)
By phone call following-up by senior neurosurgeons
Time frame: 180 days post SAH
Modified Rankin scale (mRS)
By phone call following-up by senior neurosurgeons
Time frame: 30 days and 90 days post SAH
Glosgow Coma Score (GCS)
Assessing by senior neurosurgeons
Time frame: 24 hours postoperation
Incidence of delayed cerebral ischemia
Proved by clinical and radiologic evidence
Time frame: 30 days post SAH
Incidence of herniation
Proved by clinical and radiologic evidence
Time frame: 30 days post SAH
Incidence of cerebral vasospasm
Proved by clinical and radiologic evidence
Time frame: 30 days post SAH
Incidence of rebleeding
Proved by clinical and radiologic evidence
Time frame: 30 days post SAH
Death
Time frame: 30 days post SAH
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