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

Author:

Laaksonen MikaelORCID,Rinne Jaakko,Rahi Melissa,Posti Jussi P.,Laitio Ruut,Kivelev Juri,Saarenpää Ilkka,Laukka Dan,Frösen Juhana,Ronkainen Antti,Bendel Stepani,Långsjö Jaakko,Ala-Peijari Marika,Saunavaara Jani,Parkkola Riitta,Nyman Mikko,Martikainen Ilkka K.,Dickens Alex M.,Rinne Juha,Valtonen Mika,Saari Teijo I.,Koivisto Timo,Bendel Paula,Roine Timo,Saraste Antti,Vahlberg Tero,Tanttari Juha,Laitio Timo

Abstract

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.

Funder

Biotieteiden ja Ympäristön Tutkimuksen Toimikunta

State Research Funding of South-Western Finland

Suomen Anestesiologiyhdistys

Suomen Lääketieteen Säätiö

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Medicine (miscellaneous)

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