Effect of xenon on brain injury, neurological outcome, and survival in patients after aneurysmal subarachnoid hemorrhage—study protocol for a randomized clinical trial
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
Affiliations
Mikael Laaksonen
Department of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of Turku
Jaakko Rinne
Neurocenter, Department of Neurosurgery and Turku Brain Injury Center, Turku University Hospital and University of Turku
Melissa Rahi
Neurocenter, Department of Neurosurgery and Turku Brain Injury Center, Turku University Hospital and University of Turku
Jussi P. Posti
Neurocenter, Department of Neurosurgery and Turku Brain Injury Center, Turku University Hospital and University of Turku
Ruut Laitio
Department of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of Turku
Juri Kivelev
Neurocenter, Department of Neurosurgery and Turku Brain Injury Center, Turku University Hospital and University of Turku
Ilkka Saarenpää
Neurocenter, Department of Neurosurgery and Turku Brain Injury Center, Turku University Hospital and University of Turku
Dan Laukka
Neurocenter, Department of Neurosurgery and Turku Brain Injury Center, Turku University Hospital and University of Turku
Juhana Frösen
Department of Neurosurgery, Faculty of Medicine and Health Technology, Tampere University Hospital, University of Tampere
Antti Ronkainen
Department of Neurosurgery, Faculty of Medicine and Health Technology, Tampere University Hospital, University of Tampere
Stepani Bendel
Department of Intensive Care, Kuopio University Hospital, University of Eastern Finland
Jaakko Långsjö
Department of Anesthesiology and Intensive Care, Tampere University Hospital and University of Tampere
Marika Ala-Peijari
Department of Anesthesiology and Intensive Care, Tampere University Hospital and University of Tampere
Jani Saunavaara
Department of Medical Physics, Turku University Hospital and University of Turku
Riitta Parkkola
Department of Radiology, Turku University Hospital and University of Turku
Mikko Nyman
Department of Radiology, Turku University Hospital and University of Turku
Ilkka K. Martikainen
Department of Radiology, Tampere University Hospital and University of Tampere
Alex M. Dickens
Analysis of the metabolomics, University of Turku
Juha Rinne
Turku PET Centre, Turku University Hospital and University of Turku
Mika Valtonen
Department of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of Turku
Teijo I. Saari
Department of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of Turku
Timo Koivisto
Department of Neurosurgery, Kuopio University Hospital, University of Eastern Finland
Paula Bendel
Department of Radiology, Kuopio University Hospital
Timo Roine
Department of Neuroscience and Biomedical Engineering, Aalto University School of Science
Antti Saraste
Heart Centre, Turku University Hospital, Turku University Hospital and University of Turku
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.
