Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Interventions
- Procedure: Decompressive craniectomyProcedure: Best medical treatment
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
- Arm && Interventions
Group Intervention Description Decompressive craniectomy Best medical treatment Decompressive craniectomy and best medical treatment Control Best medical treatment Only best medical treatment. Decompressive craniectomy is employed only if intracranial pressure \>25 mm Hg for 1-12 hours to keep the patients safe. Decompressive craniectomy Decompressive craniectomy Decompressive craniectomy and best medical treatment
- 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