ArticleTrials2021
Stereotactic cisternal lavage in patients with aneurysmal subarachnoid hemorrhage with urokinase and nimodipine for the prevention of secondary brain injury (SPLASH): study protocol for a randomized controlled trial.
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.
- Thrombolysis for aneurysmal subarachnoid haemorrhage.The Cochrane database of systematic reviews · 2025Pooled it
- Transcranial cisternal port enables repetitive intrathecal delivery in mice.Scientific reports · 2026Article
- Extensive peritruncal subarachnoid hemorrhage: a risk factor for the development of spinal arachnoid cysts. Illustrative cases.Journal of neurosurgery. Case lessons · 2025Article
- CSF diversion after aneurysmal sub-arachnoid hemorrhage: towards personalized treatment strategies.Critical care (London, England) · 2025Review
- The Transcranial Cisternal Port (TCP): A Novel Technique for Repetitive Intrathecal Delivery in Mice.Research square · 2025Article
- Continuous intracisternal nimodipine administration as rescue therapy for refractory vasospasm in patients with aneurysmal subarachnoid haemorrhage.Acta neurochirurgica · 2025Observational
- Prevention of Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage-Summary of Existing Clinical Evidence.Translational stroke research · 2025Review
- Treatment factors to suppress delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage based on VASOGRADE: multicenter cohort study.Neurosurgical review · 2024Observational
- Contemporary management of aneurysmal subarachnoid haemorrhage. An update for the intensivist.Intensive care medicine · 2024Review
- Cisterno-Ventricular Lavage After Aneurysm Clipping for the Prevention of Delayed Infarction in Patients With Subarachnoid Hemorrhage.Neurosurgery practice · 2023Article
- Subarachnoid Blood Clearance and Aneurysmal Subarachnoid Hemorrhage Outcomes: A Retrospective Review.Neurocritical care · 2023Article
- Targeting Hemoglobin to Reduce Delayed Cerebral Ischemia After Subarachnoid Hemorrhage.Translational stroke research · 2022Review
Corrections and comments
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Authors and funding
13 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundDelayed cerebral infarction (DCI) is a major cause of death and poor neurological outcome in patients with aneurysmal subarachnoid hemorrhage (aSAH). Direct intrathecal therapies with fibrinolytic and spasmolytic drugs have appeared promising in clinical trials. However, access to the subarachnoid space for intrathecal drug administration is an unsolved problem so far, especially in patients with endovascular aneurysm securing. We investigate a therapy protocol based on stereotactic catheter ventriculocisternostomy (STX-VCS), a new approach to overcome this problem. The primary objective of this study is to assess whether cisternal lavage with urokinase, nimodipine, and Ringer's solution administered via a stereotactically implanted catheter into the basal cisterns (= investigational treatment (IT)) is safe and improves neurological outcome in patients with aSAH.
methodsThis is a randomized, controlled, parallel-group, open-label phase II trial. Fifty-four patients with severe aSAH (WFNS grade ≥ 3) will be enrolled at one academic tertiary care center in Southern Germany. Patients will be randomized at a ratio of 1:1 to receive either standard of care only or standard of care plus the IT. The primary endpoint is the proportion of subjects with a favorable outcome on the Modified Rankin Scale (defined as mRS 0-3) at 6 months after aSAH. Further clinical and surrogate outcome parameters are defined as secondary endpoints. DISCUSSION: New approaches for the prevention and therapy of secondary brain injury in patients with aSAH are urgently needed. We propose this RCT to assess the clinical safety and efficacy of a novel therapy protocol for intrathecal administration of urokinase, nimodipine, and Ringer's solution.
trial registrationDeutsches Register Klinischer Studien (German Clinical Trials Register), DRKS00015645 . Registered on 8 May 2019.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.