University Neurosurgical Centre Holland, Leiden University Medical Centre, Haaglanden Medical Centre and Haga Hospital, Leiden and The Hague, Lijnbaanweg 32, The Hague, 2512 VA, The Netherlands.
Department of Neurosurgery, Amsterdam University Medical Centre, Amsterdam, The Netherlands.
BMC Neurol. 2024 Feb 17;24(1):68. doi: 10.1186/s12883-024-03567-6.
Ruptured intracranial aneurysms resulting in subarachnoid haemorrhage can be treated by open surgical or endovascular treatment. Despite multiple previous studies, uncertainties on the optimal treatment practice still exists. The resulting treatment variation may result in a variable, potentially worse, patient outcome. To better inform future treatment strategies, this study aims to identify the effectiveness of different treatment strategies in patients with ruptured intracranial aneurysms by investigating long-term functional outcome, complications and cost-effectiveness. An explorative analysis of the diagnostic and prognostic value of radiological imaging will also be performed.
This multi-centre observational prospective cohort study will have a follow-up of 10 years. A total of 880 adult patients with a subarachnoid haemorrhage caused by a ruptured intracranial aneurysm will be included. Calculation of sample size (N = 880) was performed to show non-inferiority of clip-reconstruction compared to endovascular treatment on 1 year outcome, assessed by using the ordinal modified Rankin Scale. The primary endpoint is the modified Rankin Scale score and mortality at 1 year after the initial subarachnoid haemorrhage. Patients will receive 'non-experimental' regular care during their hospital stay. For this study, health questionnaires and functional outcome will be assessed at baseline, before discharge and at follow-up visits.
Despite the major healthcare and societal burden, the optimal treatment strategy for patients with subarachnoid haemorrhage caused by ruptured intracranial aneurysms is yet to be determined. Findings of this comparative effectiveness study, in which in-between centre variation in practice and patient outcome are investigated, will provide evidence on the effectiveness of treatment strategies, hopefully contributing to future high value treatment standardisation.
NCT05851989 DATE OF REGISTRATION: May 10th, 2023.
破裂性颅内动脉瘤导致的蛛网膜下腔出血可以通过开颅手术或血管内治疗来治疗。尽管有多项先前的研究，但最佳治疗实践仍然存在不确定性。由此产生的治疗差异可能导致患者结果的变化，潜在地更差。为了更好地为未来的治疗策略提供信息，本研究旨在通过调查长期功能结果、并发症和成本效益，确定不同治疗策略对破裂性颅内动脉瘤患者的有效性。还将对影像学诊断和预后价值进行探索性分析。
这是一项多中心观察性前瞻性队列研究，随访时间为 10 年。总共将纳入 880 例因破裂性颅内动脉瘤引起蛛网膜下腔出血的成年患者。计算样本量（N=880）是为了在 1 年时使用改良的 Rankin 量表评估显示夹闭重建与血管内治疗的非劣效性。主要终点是初始蛛网膜下腔出血后 1 年的改良 Rankin 量表评分和死亡率。患者在住院期间将接受“非实验性”常规护理。在这项研究中，将在基线、出院前和随访时评估健康问卷和功能结果。
尽管存在重大的医疗保健和社会负担，但破裂性颅内动脉瘤引起的蛛网膜下腔出血患者的最佳治疗策略尚未确定。本比较有效性研究的结果，其中调查了中心间实践和患者结果的差异，将提供治疗策略有效性的证据，有望为未来的高价值治疗标准化做出贡献。
NCT05851989 注册日期：2023 年 5 月 10 日。
