Subarachnoid Hemorrhage, Aneurysmal Clinical Trial
Official title:
Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | July 2018 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Tandu Hospital, Fourth Military Medical University | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Tang-Du Hospital |
China,
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. — View 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. — View 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. — View 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. Epub 2007 Feb 1. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Modified Rankin scale (mRS) | By phone call following-up by senior neurosurgeons | 180 days post SAH | |
Secondary | Modified Rankin scale (mRS) | By phone call following-up by senior neurosurgeons | 30 days and 90 days post SAH | |
Secondary | Glosgow Coma Score (GCS) | Assessing by senior neurosurgeons | 24 hours postoperation | |
Secondary | Incidence of delayed cerebral ischemia | Proved by clinical and radiologic evidence | 30 days post SAH | |
Secondary | Incidence of herniation | Proved by clinical and radiologic evidence | 30 days post SAH | |
Secondary | Incidence of cerebral vasospasm | Proved by clinical and radiologic evidence | 30 days post SAH | |
Secondary | Incidence of rebleeding | Proved by clinical and radiologic evidence | 30 days post SAH | |
Secondary | Death | 30 days post SAH |
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