Umana Giuseppe E, Tomasi S Ottavio, Palmisciano Paolo, Scalia Gianluca, Da Ros Valerio, Al-Schameri Rahman, Priola Stefano M, Brunasso Lara, Giammalva Giuseppe Roberto, Paolini Federica, Costanzo Roberta, Bonosi Lapo, Gerardi Rosa Maria, Maugeri Rosario, Strigari Lidia, Stieg Philip E, Esposito Giuseppe, Lawton Michael T, Griessenauer Christoph J, Winkler Peter A
Department of Neurosurgery, Trauma Center, Gamma Knife Center, Cannizzaro Hospital, Catania, Italy.
Department of Neurological Surgery, Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria.
Front Surg. 2022 Apr 5;9:847429. doi: 10.3389/fsurg.2022.847429. eCollection 2022.
Arterial vasospasm has been ascribed as the responsible etiology of delayed cerebral infarction in patients with aneurysmal subarachnoid hemorrhage (aSAH), but other neurovascular structures may be involved. We present the protocol for a multicenter, prospective, observational study focused on analyzing morphological changes in cerebral veins of patients with aSAH.
In a retrospective arm, we will collect head arterial and venous CT angiograms (CTA) of 50 patients with aSAH and 50 matching healthy controls at days 0-2 and 7-10, comparing morphological venous changes. A multicenter prospective observational study will follow. Patients aged ≥18 years of any gender with aSAH will be enrolled at 9 participating centers based on the predetermined eligibility criteria. A sample size of 52 aSAH patients is expected, and 52 healthy controls matched per age, gender, and comorbidities will be identified. For each patient, sequential CTA will be conducted upon admission (day 0-2), at 7-10 days, and at 14-21 days after aSAH, evaluating volumes and morphology of the cerebral deep veins and main cortical veins. One specialized image collecting center will analyze all anonymized CTA scans, performing volumetric calculation of targeted veins. Morphological venous changes over time will be evaluated using the Dice coefficient and the Jaccard index and scored using the Boeckh-Behrens system. Morphological venous changes will be correlated to clinical outcomes and compared between patients with aSAH and healthy-controls, and among groups based on surgical/endovascular treatments for aSAH.
This protocol has been approved by the ethics committee and institutional review board of Ethikkommission, SALK, Salzburg, Austria, and will be approved at all participating sites. The study will comply with the Declaration of Helsinki. Written informed consent will be obtained from all enrolled patients or their legal tutors. We will present our findings at academic conferences and peer-reviewed journals.
Version 2, 09 June 2021.
动脉血管痉挛被认为是动脉瘤性蛛网膜下腔出血（aSAH）患者迟发性脑梗死的病因，但其他神经血管结构可能也参与其中。我们介绍一项多中心、前瞻性、观察性研究的方案，该研究聚焦于分析aSAH患者脑静脉的形态学变化。
在回顾性研究部分，我们将收集50例aSAH患者和50例匹配的健康对照在第0 - 2天和第7 - 10天的头部动脉和静脉CT血管造影（CTA），比较静脉形态学变化。随后将开展一项多中心前瞻性观察性研究。根据预定的纳入标准，年龄≥18岁、任何性别的aSAH患者将在9个参与中心入组。预计纳入52例aSAH患者样本，并确定52例按年龄、性别和合并症匹配的健康对照。对于每位患者，将在aSAH入院时（第0 - 2天）、第7 - 10天和第14 - 21天进行连续CTA检查，评估脑深静脉和主要皮质静脉的容积和形态。一个专业图像采集中心将分析所有匿名的CTA扫描图像，对目标静脉进行容积计算。使用骰子系数和杰卡德指数评估静脉形态随时间的变化，并采用Boeckh - Behrens系统进行评分。静脉形态学变化将与临床结局相关联，并在aSAH患者与健康对照之间以及基于aSAH手术/血管内治疗的组间进行比较。
本方案已获得奥地利萨尔茨堡SALK伦理委员会和机构审查委员会的批准，并将在所有参与站点获得批准。本研究将遵循《赫尔辛基宣言》。将从所有入组患者或其法定监护人处获得书面知情同意书。我们将在学术会议和同行评审期刊上展示我们的研究结果。
2021年6月9日版本2
