Atorvastatin for treating spontaneous subarachnoid hemorrhage: study protocol for a randomized double-blind placebo-controlled trial

Background: Animal studies have confirmed
that statins have neuroprotective effects during and following a subarachnoid
hemor­rhage; however, the therapeutic effect of statins in humans remains
controversial. The interpretation of data currently available on the clinical
application of statins to spontaneous subarachnoid hemorrhage is limited by the
small sample sizes used in the studies, making it difficult to draw valid
conclusions regarding the multiple neuroprotective effects of statins. Thus, we
propose to perform a random­ized double-blind placebo-controlled parallel-group
clinical trial to determine the effects of atorvastatin on spontaneous
subarachnoid hemorrhage, apoptosis-related factors, and serum inflammatory
factors in cerebrospinal fluid and to observe its neuroprotective effect
mediated by relieving vasospasm.

Methods/Design: This is a randomized
parallel-group placebo-controlled double-blind clinical trial. This trial will
recruit 300 patients with spontaneous subarachnoid hemorrhage from the
Department of Neurosurgery, 101st Hospital of PLA (Wuxi Taihu Hospital). These patients
will be equally and randomly assigned to atorvastatin (40 mg/day) and placebo
control groups. Outcomes will be evaluated at baseline, 3, 5, and 14 days after
hemorrhage, and 6 months after discharge. The primary outcomes will be the
results of computed tomography (CT) angiography combined with CT perfusion
imaging and conventional CT. The secondary outcomes will be cerebro­spinal
fluid analysis, blood testing (tumor necrosis factor α, vascular endothelial
growth factor, interleukin-6, and C-reactive protein levels), and the Hunt-Hess
classification, the results of transcranial Doppler ultrasonography, and the
scores on the Glasgow Coma Scale, the Glasgow Outcome Scale, and the National
Institutes of Health Stroke Scale.

Discussion: The results of this trial
will provide data on the clinical application and neuroregenerative effect of
atorvastatin in the acute stage of spontaneous subarachnoid hemorrhage.

Trial registration: This trial was registered
with the Chinese Clinical Trial Registry (ChiCTR-IPR-14005395) on 18 May 2014.

How to
cite this article: Chen JH, Wang YH (2016) Atorvastatin for treating
spontaneous subarachnoid hemorrhage: study protocol for a randomized
double-blind placebo-controlled trial. Asia Pac Clin Transl Nerv Syst Dis
1(2):62-68.