Timing of Operation for Poor-grade Aneurysmal Subarachnoid Hemorrhage: Study Protocol for a Randomized Controlled Trial

Overview

Journal BMC Neurol

Publisher Biomed Central

Specialty Neurology

Date 2013 Aug 21

PMID 23957458

Citations 4

Authors

Qiao Zhang

Lu Ma

Yi Liu

Min He

Hong Sun

Xiang Wang

Yuan Fang

Xu-Hui Hui

Chao You

Affiliations

Soon will be listed here.

Abstract

Background: Subarachnoid hemorrhage is a common and dangerous disease with an unfavorable prognosis. Patients with poor-grade subarachnoid hemorrhage (Hunt & Hess Grades 4-5) are unconscious on admission. Because of the high mortality and disability rate associated with poor-grade subarachnoid hemorrhage, it is often treated conservatively. Timing of surgery for poor-grade aneurysmal subarachnoid hemorrhage is still controversial, therefore this study aims to identify the optimal time to operate on patients admitted in poor clinical condition.

Methods/design: Ninety-nine patients meeting the inclusion criteria were randomly assigned into three treatment groups. The early surgery group received operation within 3 days after onset of subarachnoid hemorrhage (day of SAH = day 1); the intermediate surgery group received operation from days 4 to 7, and surgery was performed on the late surgery group after day 7. Follow-up was performed 1, 3, and 6 months after aneurysm clipping. Primary indicators of outcome included the Extended Glasgow Outcome Scale and the Modified Rankin Scale, while secondary indicators of outcome were assessed using the Barthel Index and mortality.

Discussion: This is the first prospective, single-center, observer-blinded, randomized controlled trial to elucidate optimal timing for surgery in poor-grade subarachnoid hemorrhage patients. The results of this study will be used to direct decisions of surgical intervention in poor-grade subarachnoid hemorrhage, thus improving clinical outcomes for patients.

Trial Registration: Chinese Clinical Trial Registry: ChiCTR-TRC-12002917.

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References

Hutchinson P, Power D, Tripathi P, Kirkpatrick P . Outcome from poor grade aneurysmal subarachnoid haemorrhage--which poor grade subarachnoid haemorrhage patients benefit from aneurysm clipping?. Br J Neurosurg. 2000; 14(2):105-9. DOI: 10.1080/02688690050004516. View

Maurice-Williams R, Lafuente J . Intracranial aneurysm surgery and its future. J R Soc Med. 2003; 96(11):540-3. PMC: 539625. DOI: 10.1177/014107680309601106. View

Inagawa T, Tokuda Y, Ohbayashi N, Takaya M, Moritake K . Study of aneurysmal subarachnoid hemorrhage in Izumo City, Japan. Stroke. 1995; 26(5):761-6. DOI: 10.1161/01.str.26.5.761. View

Shirao S, Yoneda H, Kunitsugu I, Ishihara H, Koizumi H, Suehiro E . Preoperative prediction of outcome in 283 poor-grade patients with subarachnoid hemorrhage: a project of the Chugoku-Shikoku Division of the Japan Neurosurgical Society. Cerebrovasc Dis. 2010; 30(2):105-13. DOI: 10.1159/000314713. View

Hollerhage H . Nimodipine treatment in poor-grade aneurysm patients. J Neurosurg. 1988; 69(5):803-5. View

Fogelholm R, Hernesniemi J, Vapalahti M . Impact of early surgery on outcome after aneurysmal subarachnoid hemorrhage. A population-based study. Stroke. 1993; 24(11):1649-54. DOI: 10.1161/01.str.24.11.1649. View

de Gans K, Nieuwkamp D, Rinkel G, Algra A . Timing of aneurysm surgery in subarachnoid hemorrhage: a systematic review of the literature. Neurosurgery. 2002; 50(2):336-40; discussion 340-2. DOI: 10.1097/00006123-200202000-00018. View

Iwa H, Kyoi K, Tsunoda S, Yokoyama K, Imanishi M, Utsumi S . [Clinical characteristics of contrast medium extravasation from intracranial aneurysms during cerebral angiography: studies on personal experience and review of the literature]. No Shinkei Geka. 1986; 14(3 Suppl):263-70. View

Molyneux A, Kerr R, Yu L, Clarke M, Sneade M, Yarnold J . International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding,.... Lancet. 2005; 366(9488):809-17. DOI: 10.1016/S0140-6736(05)67214-5. View

10.

Wang X, Chen J, You C, He M . Surgical management of traumatic intracranial pseudoaneurysms: a report of 12 cases. Neurol India. 2008; 56(1):47-51. DOI: 10.4103/0028-3886.39312. View

11.

Ross N, Hutchinson P, Seeley H, Kirkpatrick P . Timing of surgery for supratentorial aneurysmal subarachnoid haemorrhage: report of a prospective study. J Neurol Neurosurg Psychiatry. 2002; 72(4):480-4. PMC: 1737846. DOI: 10.1136/jnnp.72.4.480. View

12.

Ohman J, HEISKANEN O . Timing of operation for ruptured supratentorial aneurysms: a prospective randomized study. J Neurosurg. 1989; 70(1):55-60. DOI: 10.3171/jns.1989.70.1.0055. View

13.

Nieuwkamp D, de Gans K, Algra A, Albrecht K, Boomstra S, Brouwers P . Timing of aneurysm surgery in subarachnoid haemorrhage--an observational study in The Netherlands. Acta Neurochir (Wien). 2005; 147(8):815-21. DOI: 10.1007/s00701-005-0536-0. View

14.

Khandelwal P, Kato Y, Sano H, Yoneda M, Kanno T . Treatment of ruptured intracranial aneurysms: our approach. Minim Invasive Neurosurg. 2006; 48(6):325-9. DOI: 10.1055/s-2005-915633. View

15.

Ito S, Kwak R, Emori T, Nakamura T, Kadoya S, Fuji T . [Risk factors of cerebral aneurysm re-rupture during angiography]. No Shinkei Geka. 1985; 13(4):399-407. View

16.

Inagawa T . What are the actual incidence and mortality rates of subarachnoid hemorrhage?. Surg Neurol. 1997; 47(1):47-52; discussion 52-3. DOI: 10.1016/s0090-3019(96)00370-9. View

17.

Connolly Jr E, Rabinstein A, Carhuapoma J, Derdeyn C, Dion J, Higashida R . Guidelines for the management of aneurysmal subarachnoid hemorrhage: a guideline for healthcare professionals from the American Heart Association/american Stroke Association. Stroke. 2012; 43(6):1711-37. DOI: 10.1161/STR.0b013e3182587839. View

18.

Aoyagi N, Hayakawa I . Analysis of 223 ruptured intracranial aneurysms with special reference to rerupture. Surg Neurol. 1984; 21(5):445-52. DOI: 10.1016/0090-3019(84)90449-x. View

19.

Seifert V, Trost H, Stolke D . Management morbidity and mortality in grade IV and V patients with aneurysmal subarachnoid haemorrhage. Acta Neurochir (Wien). 1990; 103(1-2):5-10. DOI: 10.1007/BF01420185. View

20.

Seifert V, Stolke D, Trost H . Timing of aneurysm surgery. Comparison of results of early and delayed surgical intervention. Eur Arch Psychiatry Neurol Sci. 1988; 237(5):291-7. DOI: 10.1007/BF00450548. View