Sangeetha R P, Ramesh V J, Kamath Sriganesh, Christopher Rita, Bhat Dhananjaya I, Arvinda H R, Chakrabarti Dhritiman
Department of Neuroanaesthesia and Neurocritical Care, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India.
Department of Neurochemistry, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India.
Brain Circ. 2019 Jan-Mar;5(1):12-18. doi: 10.4103/bc.bc_26_18. Epub 2019 Mar 27.
Cerebral vasospasm is a dreaded complication of aneurysmal subarachnoid hemorrhage (aSAH) predisposing to delayed cerebral ischemia. We intend to study the cerebroprotective effects of remote ischemic preconditioning (RIPC) in patients with aSAH.
This is a single-center, prospective, parallel group, randomized, pilot trial, approved by the Institutional Ethics Committee. Patients with aSAH admitted to our hospital for surgical clipping; fulfilling the trial inclusion criteria will be randomized to true RIPC ( = 12) (inflating upper extremity blood pressure cuff thrice for 5 min to 30 mmHg above systolic blood pressure) or sham RIPC ( = 12) (inflating blood pressure cuff thrice for 5 min to 30 mmHg) in 1:1 allocation ratio using a computerized random allocation sequence and block randomization.
Our primary outcome measure is vasospasm on cerebral angiography and transcranial Doppler study, and concentration of serum S100B and neuron-specific enolase at 24 h after RIPC and on day 7 of ictus. Our secondary outcomes are safety of RIPC, cerebral oxygen saturation, and Glasgow coma score, and extended Glasgow outcome scale scores at discharge and at 1, 3, and 6 months following discharge. Outcome measures will be assessed by an observer blinded to the study intervention.
If our preliminary results demonstrate a beneficial effect of RIPC, this would serve as a clinically applicable and safe preemptive method of protection against cerebral ischemia.
脑血管痉挛是动脉瘤性蛛网膜下腔出血（aSAH）的一种可怕并发症，易导致迟发性脑缺血。我们旨在研究远程缺血预处理（RIPC）对aSAH患者的脑保护作用。
这是一项单中心、前瞻性、平行组、随机、试点试验，已获机构伦理委员会批准。因手术夹闭入住我院的aSAH患者；符合试验纳入标准的患者将按1:1分配比例，使用计算机随机分配序列和区组随机化方法，随机分为真RIPC组（n = 12）（将上肢血压袖带充气三次，每次5分钟，使血压高于收缩压30 mmHg）或假RIPC组（n = 12）（将血压袖带充气三次，每次5分钟，使血压达到30 mmHg）。
我们的主要结局指标是脑血管造影和经颅多普勒研究中的血管痉挛情况，以及RIPC后24小时和发病后第7天血清S100B和神经元特异性烯醇化酶的浓度。我们的次要结局指标是RIPC的安全性、脑氧饱和度、格拉斯哥昏迷评分，以及出院时和出院后1、3和6个月的扩展格拉斯哥预后量表评分。结局指标将由对研究干预不知情的观察者进行评估。
如果我们的初步结果证明RIPC有有益作用，这将成为一种临床适用且安全的预防脑缺血的保护方法。
