Continuous versus intermittent lumbar CSF drainage in aneurysmal arachnoid hemorrhage: a prospective, randomized controlled trial protocol
摘要
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.
MethodsThis 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.
DiscussionThis 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 registrationChiCTR2500096647 with chictr.org.cn. Registered on 27 January 2025.