Continuous versus intermittent lumbar CSF drainage in aneurysmal arachnoid hemorrhage: a prospective, randomized controlled trial protocol.

IF 2.1 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Trials Pub Date : 2026-07-09 DOI:10.1186/s13063-026-09887-x

Kuangyang Yu, Wen Tan, Lu Jiang, Jinwei Pang, Fengwang Xue, Kunyang Bao, Changren Huang, Yong Jiang, Jianhua Peng

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引用次数: 0

Abstract

Background: Hydrocephalus, as a common complication following aneurysmal subarachnoid hemorrhage (aSAH), not only leads to neurological dysfunction in patients but is also associated with a relatively high mortality rate.

Methods: This study is a prospective, single-center, randomized controlled trial. It is planned to recruit 256 patients with aSAH (parallel design, with a 1:1 allocation). Subjects will be assigned to the continuous lumbar drainage (LD) group and the intermittent LD group after undergoing surgical treatment (within 72 h). The primary outcome events will be defined as the degree of improvement in patients' 180 (± 7 days) modified Rankin Scale (mRS) and Glasgow Outcome Scale (GOS) scores, incidence of shunt-dependent hydrocephalus, and 30 days mortality after randomization. Recruitment will be finished by November 2027. All the patients will be followed for at least 180 (± 7 days). The trial is scheduled to complete in 2028.

Discussion: This study aims to explore the safety and effectiveness of different LD methods after aSAH, evaluate whether there are different impacts on the neurological prognosis of patients, and determine whether the incidence of shunt-dependent hydrocephalus varies among different methods. It is intended to provide high-quality evidence-based medical evidence for the clinical management of hydrocephalus after aSAH.

Trial registration: ChiCTR2500096647 with chictr.org.cn. Registered on 27 January 2025.

查看原文本刊更多论文

连续与间歇腰椎脑脊液引流治疗动脉瘤性蛛网膜出血：一项前瞻性、随机对照试验方案。

背景：脑积水是动脉瘤性蛛网膜下腔出血（aSAH）后常见的并发症，不仅会导致患者神经功能障碍，而且死亡率相对较高。方法：本研究为前瞻性、单中心、随机对照试验。计划招募256例aSAH患者（平行设计，1:1分配）。受试者在手术治疗后（72小时内）分为连续腰椎引流组（LD）和间歇腰椎引流组（LD）。主要结局事件将被定义为患者180（±7天）改良Rankin量表（mRS）和格拉斯哥结局量表（GOS）评分的改善程度、分流依赖性脑积水发生率和随机化后30天死亡率。招聘将于2027年11月结束。所有患者至少随访180天（±7天）。试验计划于2028年完成。讨论：本研究旨在探讨aSAH后不同LD方法的安全性和有效性，评估其对患者神经预后的影响是否不同，确定不同方法对分流依赖性脑积水的发生率是否存在差异。旨在为aSAH后脑积水的临床处理提供高质量的循证医学依据。试验注册：ChiCTR2500096647，登陆chictr.org.cn。于2025年1月27日注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Trials 医学-医学：研究与实验

CiteScore

3.80

自引率

4.00%

发文量

966

审稿时长

6 months

期刊介绍： Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.