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
Abstract Background Delayed 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 t...
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| Format: | Article |
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BMC
2021-04-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05208-6 |
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| author | Roland Roelz Fabian Schubach Volker A. Coenen Carolin Jenkner Christian Scheiwe Jürgen Grauvogel Wolf-Dirk Niesen Horst Urbach Christian Taschner Jochen Seufert Jürgen Kätzler Jürgen Beck Peter C. Reinacher |
| author_facet | Roland Roelz Fabian Schubach Volker A. Coenen Carolin Jenkner Christian Scheiwe Jürgen Grauvogel Wolf-Dirk Niesen Horst Urbach Christian Taschner Jochen Seufert Jürgen Kätzler Jürgen Beck Peter C. Reinacher |
| author_sort | Roland Roelz |
| collection | DOAJ |
| description | Abstract Background Delayed 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. Methods This 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 registration Deutsches Register Klinischer Studien (German Clinical Trials Register), DRKS00015645 . Registered on 8 May 2019 |
| first_indexed | 2024-12-14T19:50:20Z |
| format | Article |
| id | doaj.art-7405febb871e4b1d97e968085503ea7b |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-14T19:50:20Z |
| publishDate | 2021-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-7405febb871e4b1d97e968085503ea7b2022-12-21T22:49:26ZengBMCTrials1745-62152021-04-0122111510.1186/s13063-021-05208-6Stereotactic 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 trialRoland Roelz0Fabian Schubach1Volker A. Coenen2Carolin Jenkner3Christian Scheiwe4Jürgen Grauvogel5Wolf-Dirk Niesen6Horst Urbach7Christian Taschner8Jochen Seufert9Jürgen Kätzler10Jürgen Beck11Peter C. Reinacher12Department of Neurosurgery, Medical Center – University of Freiburg, Faculty of Medicine, University of FreiburgClinical Trials Unit, Medical Center – University of Freiburg, Faculty of Medicine, University of FreiburgDepartment of Stereotactic and Functional Neurosurgery, Medical Center – University of Freiburg, Faculty of Medicine, University of FreiburgClinical Trials Unit, Medical Center – University of Freiburg, Faculty of Medicine, University of FreiburgDepartment of Neurosurgery, Medical Center – University of Freiburg, Faculty of Medicine, University of FreiburgDepartment of Neurosurgery, Medical Center – University of Freiburg, Faculty of Medicine, University of FreiburgDepartment of Neurology and Neurophysiology, Medical Center – University of Freiburg, Faculty of Medicine, University of FreiburgDepartment of Neuroradiology, Medical Center – University of Freiburg, Faculty of Medicine, University of FreiburgDepartment of Neuroradiology, Medical Center – University of Freiburg, Faculty of Medicine, University of FreiburgDepartment of Medicine II, Division of Endocrinology and Diabetology, Medical Center – University of Freiburg, Faculty of Medicine, University of FreiburgDepartment of Internal Medicine III, Clinical Trials Office, University Medical Center UlmDepartment of Neurosurgery, Medical Center – University of Freiburg, Faculty of Medicine, University of FreiburgDepartment of Stereotactic and Functional Neurosurgery, Medical Center – University of Freiburg, Faculty of Medicine, University of FreiburgAbstract Background Delayed 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. Methods This 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 registration Deutsches Register Klinischer Studien (German Clinical Trials Register), DRKS00015645 . Registered on 8 May 2019https://doi.org/10.1186/s13063-021-05208-6Delayed cerebral infarction (DCI)Aneurysmal subarachnoid hemorrhage (aSAH)Clinical trialStereotactic ventriculocisternostomy (STX-VCS)UrokinaseNimodipine |
| spellingShingle | Roland Roelz Fabian Schubach Volker A. Coenen Carolin Jenkner Christian Scheiwe Jürgen Grauvogel Wolf-Dirk Niesen Horst Urbach Christian Taschner Jochen Seufert Jürgen Kätzler Jürgen Beck Peter C. Reinacher 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 Trials Delayed cerebral infarction (DCI) Aneurysmal subarachnoid hemorrhage (aSAH) Clinical trial Stereotactic ventriculocisternostomy (STX-VCS) Urokinase Nimodipine |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Delayed cerebral infarction (DCI) Aneurysmal subarachnoid hemorrhage (aSAH) Clinical trial Stereotactic ventriculocisternostomy (STX-VCS) Urokinase Nimodipine |
| url | https://doi.org/10.1186/s13063-021-05208-6 |
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