Effect of xenon on brain injury, neurological outcome, and survival in patients after aneurysmal subarachnoid hemorrhage—study protocol for a randomized clinical trial
Abstract Background Aneurysmal subarachnoid hemorrhage (aSAH) is a neurological emergency, affecting a younger population than individuals experiencing an ischemic stroke; aSAH is associated with a high risk of mortality and permanent disability. The noble gas xenon has been shown to possess neuropr...
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BMC
2023-06-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07432-8 |
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| author | Mikael Laaksonen Jaakko Rinne Melissa Rahi Jussi P. Posti Ruut Laitio Juri Kivelev Ilkka Saarenpää Dan Laukka Juhana Frösen Antti Ronkainen Stepani Bendel Jaakko Långsjö Marika Ala-Peijari Jani Saunavaara Riitta Parkkola Mikko Nyman Ilkka K. Martikainen Alex M. Dickens Juha Rinne Mika Valtonen Teijo I. Saari Timo Koivisto Paula Bendel Timo Roine Antti Saraste Tero Vahlberg Juha Tanttari Timo Laitio |
| author_facet | Mikael Laaksonen Jaakko Rinne Melissa Rahi Jussi P. Posti Ruut Laitio Juri Kivelev Ilkka Saarenpää Dan Laukka Juhana Frösen Antti Ronkainen Stepani Bendel Jaakko Långsjö Marika Ala-Peijari Jani Saunavaara Riitta Parkkola Mikko Nyman Ilkka K. Martikainen Alex M. Dickens Juha Rinne Mika Valtonen Teijo I. Saari Timo Koivisto Paula Bendel Timo Roine Antti Saraste Tero Vahlberg Juha Tanttari Timo Laitio |
| author_sort | Mikael Laaksonen |
| collection | DOAJ |
| description | Abstract Background Aneurysmal subarachnoid hemorrhage (aSAH) is a neurological emergency, affecting a younger population than individuals experiencing an ischemic stroke; aSAH is associated with a high risk of mortality and permanent disability. The noble gas xenon has been shown to possess neuroprotective properties as demonstrated in numerous preclinical animal studies. In addition, a recent study demonstrated that xenon could attenuate a white matter injury after out-of-hospital cardiac arrest. Methods The study is a prospective, multicenter phase II clinical drug trial. The study design is a single-blind, prospective superiority randomized two-armed parallel follow-up study. The primary objective of the study is to explore the potential neuroprotective effects of inhaled xenon, when administered within 6 h after the onset of symptoms of aSAH. The primary endpoint is the extent of the global white matter injury assessed with magnetic resonance diffusion tensor imaging of the brain. Discussion Despite improvements in medical technology and advancements in medical science, aSAH mortality and disability rates have remained nearly unchanged for the past 10 years. Therefore, new neuroprotective strategies to attenuate the early and delayed brain injuries after aSAH are needed to reduce morbidity and mortality. Trial registration ClinicalTrials.gov NCT04696523. Registered on 6 January 2021. EudraCT, EudraCT Number: 2019-001542-17. Registered on 8 July 2020. |
| first_indexed | 2024-03-13T03:19:20Z |
| format | Article |
| id | doaj.art-9d946299390741bfa6d617d14bb790b5 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-13T03:19:20Z |
| publishDate | 2023-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-9d946299390741bfa6d617d14bb790b52023-06-25T11:26:57ZengBMCTrials1745-62152023-06-0124111710.1186/s13063-023-07432-8Effect of xenon on brain injury, neurological outcome, and survival in patients after aneurysmal subarachnoid hemorrhage—study protocol for a randomized clinical trialMikael Laaksonen0Jaakko Rinne1Melissa Rahi2Jussi P. Posti3Ruut Laitio4Juri Kivelev5Ilkka Saarenpää6Dan Laukka7Juhana Frösen8Antti Ronkainen9Stepani Bendel10Jaakko Långsjö11Marika Ala-Peijari12Jani Saunavaara13Riitta Parkkola14Mikko Nyman15Ilkka K. Martikainen16Alex M. Dickens17Juha Rinne18Mika Valtonen19Teijo I. Saari20Timo Koivisto21Paula Bendel22Timo Roine23Antti Saraste24Tero Vahlberg25Juha Tanttari26Timo Laitio27Department of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of TurkuNeurocenter, Department of Neurosurgery and Turku Brain Injury Center, Turku University Hospital and University of TurkuNeurocenter, Department of Neurosurgery and Turku Brain Injury Center, Turku University Hospital and University of TurkuNeurocenter, Department of Neurosurgery and Turku Brain Injury Center, Turku University Hospital and University of TurkuDepartment of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of TurkuNeurocenter, Department of Neurosurgery and Turku Brain Injury Center, Turku University Hospital and University of TurkuNeurocenter, Department of Neurosurgery and Turku Brain Injury Center, Turku University Hospital and University of TurkuNeurocenter, Department of Neurosurgery and Turku Brain Injury Center, Turku University Hospital and University of TurkuDepartment of Neurosurgery, Faculty of Medicine and Health Technology, Tampere University Hospital, University of TampereDepartment of Neurosurgery, Faculty of Medicine and Health Technology, Tampere University Hospital, University of TampereDepartment of Intensive Care, Kuopio University Hospital, University of Eastern FinlandDepartment of Anesthesiology and Intensive Care, Tampere University Hospital and University of TampereDepartment of Anesthesiology and Intensive Care, Tampere University Hospital and University of TampereDepartment of Medical Physics, Turku University Hospital and University of TurkuDepartment of Radiology, Turku University Hospital and University of TurkuDepartment of Radiology, Turku University Hospital and University of TurkuDepartment of Radiology, Tampere University Hospital and University of TampereAnalysis of the metabolomics, University of TurkuTurku PET Centre, Turku University Hospital and University of TurkuDepartment of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of TurkuDepartment of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of TurkuDepartment of Neurosurgery, Kuopio University Hospital, University of Eastern FinlandDepartment of Radiology, Kuopio University HospitalDepartment of Neuroscience and Biomedical Engineering, Aalto University School of ScienceHeart Centre, Turku University Hospital, Turku University Hospital and University of TurkuDepartment of Biostatistics, University of TurkuTechnical Analysis, Elomatic Consulting & EngineeringDepartment of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of TurkuAbstract Background Aneurysmal subarachnoid hemorrhage (aSAH) is a neurological emergency, affecting a younger population than individuals experiencing an ischemic stroke; aSAH is associated with a high risk of mortality and permanent disability. The noble gas xenon has been shown to possess neuroprotective properties as demonstrated in numerous preclinical animal studies. In addition, a recent study demonstrated that xenon could attenuate a white matter injury after out-of-hospital cardiac arrest. Methods The study is a prospective, multicenter phase II clinical drug trial. The study design is a single-blind, prospective superiority randomized two-armed parallel follow-up study. The primary objective of the study is to explore the potential neuroprotective effects of inhaled xenon, when administered within 6 h after the onset of symptoms of aSAH. The primary endpoint is the extent of the global white matter injury assessed with magnetic resonance diffusion tensor imaging of the brain. Discussion Despite improvements in medical technology and advancements in medical science, aSAH mortality and disability rates have remained nearly unchanged for the past 10 years. Therefore, new neuroprotective strategies to attenuate the early and delayed brain injuries after aSAH are needed to reduce morbidity and mortality. Trial registration ClinicalTrials.gov NCT04696523. Registered on 6 January 2021. EudraCT, EudraCT Number: 2019-001542-17. Registered on 8 July 2020.https://doi.org/10.1186/s13063-023-07432-8XenonNeuroprotectionAneurysmal subarachnoid hemorrhageaSAHRandomized controlled trial |
| spellingShingle | Mikael Laaksonen Jaakko Rinne Melissa Rahi Jussi P. Posti Ruut Laitio Juri Kivelev Ilkka Saarenpää Dan Laukka Juhana Frösen Antti Ronkainen Stepani Bendel Jaakko Långsjö Marika Ala-Peijari Jani Saunavaara Riitta Parkkola Mikko Nyman Ilkka K. Martikainen Alex M. Dickens Juha Rinne Mika Valtonen Teijo I. Saari Timo Koivisto Paula Bendel Timo Roine Antti Saraste Tero Vahlberg Juha Tanttari Timo Laitio Effect of xenon on brain injury, neurological outcome, and survival in patients after aneurysmal subarachnoid hemorrhage—study protocol for a randomized clinical trial Trials Xenon Neuroprotection Aneurysmal subarachnoid hemorrhage aSAH Randomized controlled trial |
| title | Effect of xenon on brain injury, neurological outcome, and survival in patients after aneurysmal subarachnoid hemorrhage—study protocol for a randomized clinical trial |
| title_full | Effect of xenon on brain injury, neurological outcome, and survival in patients after aneurysmal subarachnoid hemorrhage—study protocol for a randomized clinical trial |
| title_fullStr | Effect of xenon on brain injury, neurological outcome, and survival in patients after aneurysmal subarachnoid hemorrhage—study protocol for a randomized clinical trial |
| title_full_unstemmed | Effect of xenon on brain injury, neurological outcome, and survival in patients after aneurysmal subarachnoid hemorrhage—study protocol for a randomized clinical trial |
| title_short | Effect of xenon on brain injury, neurological outcome, and survival in patients after aneurysmal subarachnoid hemorrhage—study protocol for a randomized clinical trial |
| title_sort | effect of xenon on brain injury neurological outcome and survival in patients after aneurysmal subarachnoid hemorrhage study protocol for a randomized clinical trial |
| topic | Xenon Neuroprotection Aneurysmal subarachnoid hemorrhage aSAH Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-023-07432-8 |
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