Dawley Troy, Claus Chad F, Tong Doris, Rajamand Sina, Sigler Diana, Bahoura Matthew, Garmo Lucas, Soo Teck M, Kelkar Prashant, Richards Boyd
Division of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.
Division of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA
BMJ Open. 2020 Oct 5;10(10):e036217. doi: 10.1136/bmjopen-2019-036217.
Delayed cerebral ischaemia (DCI) due to cerebral vasospasm (cVS) remains the foremost contributor to morbidity and mortality following aneurysmal subarachnoid haemorrhage (aSAH). Past efforts in preventing and treating DCI have failed to make any significant progress. To date, our most effective treatment involves the use of nimodipine, a calcium channel blocker. Recent studies have suggested that cilostazol, a platelet aggregation inhibitor, may prevent cVS. Thus far, no study has evaluated the effect of cilostazol plus nimodipine on the rate of DCI following aSAH.
This is a multicentre, double-blinded, randomised, placebo-controlled superiority trial investigating the effect of cilostazol on DCI. Data concerning rates of DCI, symptomatic and radiographic vasospasm, length of intensive care unit stay, and long-term functional and quality-of-life (QoL) outcomes will be recorded. All data will be collected with the aim of demonstrating that the use of cilostazol plus nimodipine will safely decrease the incidence of DCI, and decrease the rates of both radiographic and symptomatic vasospasm with subsequent improvement in long-term functional and QoL outcomes when compared with nimodipine alone.
Ethical approval was obtained from all participating hospitals by the Ascension Providence Hospital Institutional Review Board. The results of this study will be submitted for publication in peer-reviewed journals.
NCT04148105.
因脑血管痉挛（cVS）导致的迟发性脑缺血（DCI）仍然是动脉瘤性蛛网膜下腔出血（aSAH）后发病和死亡的首要原因。过去在预防和治疗DCI方面的努力未能取得任何显著进展。迄今为止，我们最有效的治疗方法是使用钙通道阻滞剂尼莫地平。最近的研究表明，血小板聚集抑制剂西洛他唑可能预防脑血管痉挛。到目前为止，尚无研究评估西洛他唑联合尼莫地平对aSAH后DCI发生率的影响。
这是一项多中心、双盲、随机、安慰剂对照的优效性试验，旨在研究西洛他唑对DCI的影响。将记录有关DCI发生率、症状性和影像学血管痉挛、重症监护病房住院时间以及长期功能和生活质量（QoL）结果的数据。收集所有数据的目的是证明，与单独使用尼莫地平相比，使用西洛他唑联合尼莫地平将安全地降低DCI的发生率，并降低影像学和症状性血管痉挛的发生率，进而改善长期功能和QoL结果。
所有参与医院均获得了阿森松普罗维登斯医院机构审查委员会的伦理批准。本研究结果将提交至同行评审期刊发表。
NCT04148105。
