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Open Access Study protocol

Timing of operation for poor-grade aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial

Qiao Zhang, Lu Ma, Yi Liu, Min He, Hong Sun, Xiang Wang, Yuan Fang, Xu-hui Hui and Chao You*

Author Affiliations

Department of Neurosurgery, West China Hospital, Sichuan University, No.37 Guoxue Alley, Chengdu, Sichuan Province 610041, People’s Republic of China

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BMC Neurology 2013, 13:108  doi:10.1186/1471-2377-13-108

Published: 19 August 2013

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

Keywords:
Timing of surgery; Poor-grade; Subarachnoid hemorrhage; ICP; Prognosis