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

Not Applicable

• Conditions: Subarachnoid Hemorrhage, Aneurysmal

• Registration Number: NCT02995928
• Lead Sponsor: Tang-Du Hospital

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.

Study Timeline

• Study First Submitted: 2016-11-27
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-19
• Status Verified: 2017-03
• Study Start: 2017-05-04
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-05-10
• Primary Completion: 2018-04
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Modified Rankin scale (mRS)	180 days post SAH	By phone call following-up by senior neurosurgeons

Secondary Outcome Measures

Name	Time	Method
Modified Rankin scale (mRS)	30 days and 90 days post SAH	By phone call following-up by senior neurosurgeons
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
Incidence of cerebral vasospasm	30 days post SAH	Proved by clinical and radiologic evidence
Incidence of rebleeding	30 days post SAH	Proved by clinical and radiologic evidence
Death	30 days post SAH

Trial Locations

Locations (1)

Tandu Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China