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

Tang-Du Hospital

Status: Unknown

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Treatments: Procedure: Best medical treatment; Procedure: Decompressive craniectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02995928

TDSJWKDC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Decompressive craniectomy

Experimental group

Description:

Decompressive craniectomy and best medical treatment

Treatment:

Procedure: Best medical treatment

Procedure: Decompressive craniectomy

Control

Active Comparator group

Description:

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

Treatment:

Procedure: Best medical treatment