Subarachnoid Hemorrhage, Aneurysmal
Conditions
Keywords
Subarachnoid Hemorrhage, Decompressive Craniectomy, Cerebral Aneurysm
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREDecompressive craniectomy
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.
PROCEDUREBest medical treatment
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.
Sponsors
Tang-Du Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age\>18yrs and age\<60yrs * It shows subarachnoid hemorrhage (SAH) based on computed tomography (CT) scan on admission * Aneurysmal subarachnoid hemorrhage confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA) * Presentation to our institution in World Federation of Neurological Societies (WFNS) Grade III to V neurological condition with Lateral hematoma * Duration from onset to admission is within 48 hours
Exclusion criteria
* Traumatic subarachnoid hemorrhage * Patients with cerebral herniation or highly possible to occur before surgery * Neurosurgery contraindicated * Patients with obvious evidence of acute hydrocephalus on admission * Intracranial aneurysm combined with cerebral arteriovenous malformation * Patients with obvious evidence of irreparable brainstem or thalamic injury * Duration from onset to admission is more than 48 hours * Disturbance of communication or poor compliance to blood collection, imageological examination and follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin scale (mRS) | 180 days post SAH | By phone call following-up by senior neurosurgeons |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glosgow Coma Score (GCS) | 24 hours postoperation | Assessing by senior neurosurgeons |
| Incidence of delayed cerebral ischemia | 30 days post SAH | Proved by clinical and radiologic evidence |
| Incidence of herniation | 30 days post SAH | Proved by clinical and radiologic evidence |
| Modified Rankin scale (mRS) | 30 days and 90 days post SAH | By phone call following-up by senior neurosurgeons |
| Incidence of rebleeding | 30 days post SAH | Proved by clinical and radiologic evidence |
| Death | 30 days post SAH | — |
| Incidence of cerebral vasospasm | 30 days post SAH | Proved by clinical and radiologic evidence |
Countries
China
Contacts
Primary ContactYan Qu, M.D Ph.D
Backup ContactMin Li, M.D Ph.D
Outcome results
None listed