Gathier C S, van den Bergh W M, Slooter A J C
Department of Intensive Care, University Medical Centre Utrecht, Utrecht, The Netherlands.
Int J Stroke. 2014 Apr;9(3):375-80. doi: 10.1111/ijs.12055. Epub 2013 May 22.
Delayed cerebral ischemia (DCI) is a major complication after aneurysmal subarachnoid hemorrhage (SAH). One option to treat delayed cerebral ischemia is to use induced hypertension, but its efficacy on the eventual outcome has not been proven in a randomized clinical trial. This article describes the design of the HIMALAIA trial (Hypertension Induction in the Management of AneurysmaL subArachnoid haemorrhage with secondary IschaemiA), designed to assess the effectiveness of induced hypertension on neurological outcome in patients with DCI after SAH.
To investigate whether induced hypertension improves the functional outcome in patients with delayed cerebral ischemia after SAH.
The HIMALAIA trial is a multicenter, singe-blinded, randomized controlled trial in patients with DCI after a recent SAH. Eligible patients will be randomized to either induced hypertension (n = 120) or to no induced hypertension (n = 120). In selected centers, the efficacy of induced hypertension in augmenting cerebral blood flow will be measured by means of cerebral perfusion computerized tomography scanning. Follow-up assessments will be performed at 3 and 12 months after randomization by trial nurses who are blinded to the treatment allocation and management. We will include patients during five years.
The primary outcome is the proportion of subarachnoid hemorrhage patients with delayed cerebral ischemia with poor outcome three-months after randomization, defined as a modified Rankin scale of more than 3. Secondary outcome measures are related to treatment failure, functional outcome, adverse events, and cerebral hemodynamics. The HIMALAIA trial is registered at clinicaltrials.gov under identifier NCT01613235.
迟发性脑缺血（DCI）是动脉瘤性蛛网膜下腔出血（SAH）后的一种主要并发症。治疗迟发性脑缺血的一种选择是采用诱导性高血压，但在随机临床试验中，其对最终结局的疗效尚未得到证实。本文描述了HIMALAIA试验（动脉瘤性蛛网膜下腔出血伴继发性缺血患者高血压诱导治疗）的设计，该试验旨在评估诱导性高血压对SAH后DCI患者神经功能结局的有效性。
研究诱导性高血压是否能改善SAH后迟发性脑缺血患者的功能结局。
HIMALAIA试验是一项针对近期SAH后DCI患者的多中心、单盲、随机对照试验。符合条件的患者将被随机分为诱导性高血压组（n = 120）或非诱导性高血压组（n = 120）。在选定的中心，将通过脑灌注计算机断层扫描测量诱导性高血压增加脑血流量的疗效。由对治疗分配和管理不知情的试验护士在随机分组后3个月和12个月进行随访评估。我们将在五年内纳入患者。
主要结局是随机分组后三个月结局不佳的蛛网膜下腔出血伴迟发性脑缺血患者的比例，定义为改良Rankin量表评分大于3。次要结局指标与治疗失败、功能结局、不良事件和脑血流动力学有关。HIMALAIA试验已在clinicaltrials.gov上注册，标识符为NCT01613235。
