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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decompressive craniectomy | Experimental | Decompressive craniectomy and best medical treatment |
|
| Control | Active Comparator | Only best medical treatment. Decompressive craniectomy is employed only if intracranial pressure >25 mm Hg for 1-12 hours to keep the patients safe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decompressive craniectomy | Procedure | Decompressive craniectomy: All patients in the treatment group will receive decompressive craniectomy of at least 12 cm according to institutional guidelines and a published surgical protocol during the clipping surgery within 48 hours form the onset. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin scale (mRS) | By phone call following-up by senior neurosurgeons | 180 days post SAH |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin scale (mRS) | By phone call following-up by senior neurosurgeons | 30 days and 90 days post SAH |
| Glosgow Coma Score (GCS) | Assessing by senior neurosurgeons |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Qu, M.D Ph.D | Contact | 86-18629074363 | yanqu0123@icloud.com | |
| Min Li, M.D Ph.D | Contact | 86-15319053136 | neursylm@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tandu Hospital, Fourth Military Medical University | Recruiting | Xi'an | Shaanxi | 710038 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18946217 | Background | 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. | |
| 24514267 |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D056424 | Decompressive Craniectomy |
| ID | Term |
|---|---|
| D019299 | Decompression, Surgical |
| D013514 | Surgical Procedures, Operative |
| D003399 | Craniotomy |
| D019635 | Neurosurgical Procedures |
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|
| Best medical treatment | Procedure | Best medical treatment: Best medical treatment is based on American Heart Association/American Stroke Association (AHA/ASA) and European Stroke Organisation (ESO) as published in the current protocol from 2012 and 2013 respectively. |
|
| 24 hours postoperation |
| Incidence of delayed cerebral ischemia | Proved by clinical and radiologic evidence | 30 days post SAH |
| Incidence of herniation | Proved by clinical and radiologic evidence | 30 days post SAH |
| Incidence of cerebral vasospasm | Proved by clinical and radiologic evidence | 30 days post SAH |
| Incidence of rebleeding | Proved by clinical and radiologic evidence | 30 days post SAH |
| Death | 30 days post SAH |
| Background |
| 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. |
| 25400113 | Background | 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. |
| 21492596 | Background | 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. |
| 17272765 | Background | 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. |
| 25817570 | Background | 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. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020765 | Intracranial Arterial Diseases |
| D000783 | Aneurysm |