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.DiscussionNew 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
Highlights
Background and rationale {6a} Aneurysmal subarachnoid hemorrhage results from the rupture of an intracranial aneurysm
New approaches for the prevention and therapy of secondary brain injury in patients with aneurysmal subarachnoid hemorrhage (aSAH) are urgently needed. We propose this Randomized controlled trial (RCT) to assess the clinical safety and efficacy of a novel therapy protocol for intrathecal administration of urokinase, nimodipine, and Ringer’s solution
Delayed cerebral infarction (DCI) is a major cause of death and poor neurological outcome in patients with aSAH
Summary
Background and rationale {6a} Aneurysmal subarachnoid hemorrhage (aSAH) results from the rupture of an intracranial aneurysm. It represents a medical catastrophe as it confers a high rate of poor neurological outcome and death [1]. The major mechanism of secondary brain injury is delayed cerebral infarction (DCI) [4, 5]. Delayed cerebral infarction (DCI) is a major cause of death and poor neurological outcome in patients with aneurysmal subarachnoid hemorrhage (aSAH). Access to the subarachnoid space for intrathecal drug administration is an unsolved problem so far, especially in patients with endovascular aneurysm securing. 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
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