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

Autor: 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
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Trials, Vol 24, Iss 1, Pp 1-17 (2023)
Druh dokumentu: article
ISSN: 1745-6215
DOI: 10.1186/s13063-023-07432-8
Popis: 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.
Databáze: Directory of Open Access Journals
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