Effect of xenon on brain injury, neurological outcome, and survival in patients after aneurysmal subarachnoid hemorrhage—study protocol for a randomized clinical trial

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Journal Title
Journal ISSN
Volume Title
A1 Alkuperäisartikkeli tieteellisessä aikakauslehdessä
Date
2023-12
Major/Subject
Mcode
Degree programme
Language
en
Pages
17
1-17
Series
Trials, Volume 24, issue 1
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.
Description
Funding Information: TL has received funding from the Academy of Finland (# 333010) and from the State Research Funding. ML has received personal research grants from the Finnish Medical Foundation and the Finnish Society of Anaesthesiologists. Publisher Copyright: © 2023, The Author(s).
Keywords
Aneurysmal subarachnoid hemorrhage, aSAH, Neuroprotection, Randomized controlled trial, Xenon
Other note
Citation
Laaksonen , M , Rinne , J , Rahi , M , Posti , J P , Laitio , R , Kivelev , J , Saarenpää , I , Laukka , D , Frösen , J , Ronkainen , A , Bendel , S , Långsjö , J , Ala-Peijari , M , Saunavaara , J , Parkkola , R , Nyman , M , Martikainen , I K , Dickens , A M , Rinne , J , Valtonen , M , Saari , T I , Koivisto , T , Bendel , P , Roine , T , Saraste , A , Vahlberg , T , Tanttari , J & Laitio , T 2023 , ' Effect of xenon on brain injury, neurological outcome, and survival in patients after aneurysmal subarachnoid hemorrhage—study protocol for a randomized clinical trial ' , Trials , vol. 24 , no. 1 , 417 , pp. 1-17 . https://doi.org/10.1186/s13063-023-07432-8