Clinical trial NCT02995928: Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage
Official title: Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Keywords: Subarachnoid Hemorrhage
Decompressive Craniectomy
Cerebral Aneurysm
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Rankin scale (mRS)
timeFrame: 180 days post SAH
Secondary outcomes:
measure: Modified Rankin scale (mRS)
timeFrame: 30 days and 90 days post SAH
measure: Glosgow Coma Score (GCS)
timeFrame: 24 hours postoperation
measure: Incidence of delayed cerebral ischemia
timeFrame: 30 days post SAH
measure: Incidence of herniation
timeFrame: 30 days post SAH
measure: Incidence of cerebral vasospasm
timeFrame: 30 days post SAH
measure: Incidence of rebleeding
timeFrame: 30 days post SAH
measure: Death
timeFrame: 30 days post SAH
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tandu Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
References:
citation: Otani N, Takasato Y, Masaoka H, Hayakawa T, Yoshino Y, Yatsushige H, Miyawaki H, Sumiyoshi K, Chikashi A, Takeuchi S, Suzuki G. Surgical outcome following decompressive craniectomy for poor-grade aneurysmal subarachnoid hemorrhage in patients with associated massive intracerebral or Sylvian hematomas. Cerebrovasc Dis. 2008;26(6):612-7. doi: 10.1159/000165115. Epub 2008 Oct 23.
citation: Uozumi Y, Sakowitz O, Orakcioglu B, Santos E, Kentar M, Haux D, Unterberg A. Decompressive craniectomy in patients with aneurysmal subarachnoid hemorrhage: a single-center matched-pair analysis. Cerebrovasc Dis. 2014;37(2):109-15. doi: 10.1159/000356979. Epub 2014 Feb 7.
citation: Lu X, Huang B, Zheng J, Tao Y, Yu W, Tang L, Zhu R, Li S, Li L. Decompressive craniectomy for the treatment of malignant infarction of the middle cerebral artery. Sci Rep. 2014 Nov 17;4:7070. doi: 10.1038/srep07070.
citation: Dorfer C, Frick A, Knosp E, Gruber A. Decompressive hemicraniectomy after aneurysmal subarachnoid hemorrhage. World Neurosurg. 2010 Oct-Nov;74(4-5):465-71. doi: 10.1016/j.wneu.2010.08.001. Epub 2011 Jan 12.
citation: Schirmer CM, Hoit DA, Malek AM. Decompressive hemicraniectomy for the treatment of intractable intracranial hypertension after aneurysmal subarachnoid hemorrhage. Stroke. 2007 Mar;38(3):987-92. doi: 10.1161/01.STR.0000257962.58269.e2. Epub 2007 Feb 1.
citation: Zhao B, Zhao Y, Tan X, Cao Y, Wu J, Zhong M, Wang S. Primary decompressive craniectomy for poor-grade middle cerebral artery aneurysms with associated intracerebral hemorrhage. Clin Neurol Neurosurg. 2015 Jun;133:1-5. doi: 10.1016/j.clineuro.2015.03.009. Epub 2015 Mar 14.