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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-04

Study Completion Date

2018-07-31

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.

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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.

Conditions

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Subarachnoid Hemorrhage, Aneurysmal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Decompressive craniectomy

Decompressive craniectomy and best medical treatment

Group Type EXPERIMENTAL

Decompressive craniectomy

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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.

Control

Only best medical treatment. Decompressive craniectomy is employed only if intracranial pressure \>25 mm Hg for 1-12 hours to keep the patients safe.

Group Type ACTIVE_COMPARATOR

Best medical treatment

Intervention Type PROCEDURE

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.

Interventions

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Decompressive 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.

Intervention Type PROCEDURE

Best 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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No