Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage

Study Overview
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Brief Summary
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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
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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.

Official Title
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Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage

Conditions
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Subarachnoid Hemorrhage, Aneurysmal

Intervention / Treatment
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* Procedure: Decompressive craniectomy
* Procedure: Best medical treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decompressive craniectomy<br>Decompressive craniectomy and best medical treatment | Procedure: Decompressive craniectomy<br>* 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.<br>Procedure: Best medical treatment<br>* 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.<br>|
| Active Comparator: Control<br>Only best medical treatment. Decompressive craniectomy is employed only if intracranial pressure >25 mm Hg for 1-12 hours to keep the patients safe. | Procedure: Best medical treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin scale (mRS) | By phone call following-up by senior neurosurgeons | 180 days post SAH | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin scale (mRS) | By phone call following-up by senior neurosurgeons | 30 days and 90 days post SAH | 
| Glosgow Coma Score (GCS) | Assessing by senior neurosurgeons | 24 hours postoperation | 
| Incidence of delayed cerebral ischemia | Proved by clinical and radiologic evidence | 30 days post SAH | 
| Incidence of herniation | Proved by clinical and radiologic evidence | 30 days post SAH | 
| Incidence of cerebral vasospasm | Proved by clinical and radiologic evidence | 30 days post SAH | 
| Incidence of rebleeding | Proved by clinical and radiologic evidence | 30 days post SAH | 
| Death |  | 30 days post SAH | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subarachnoid Hemorrhage, Decompressive Craniectomy, Cerebral Aneurysm