Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage
Status:
Not yet recruiting
Trial end date:
2027-12-31
Target enrollment:
Participant gender:
Summary
An investigator-initiated clinical drug study
Main Objective:
To explore neuroprotective properties of xenon in patients after aneurysmal subarachnoid
hemorrhage (SAH).
Primary endpoint: Global fractional anisotropy of white matter of diffusion tensor imaging
(DTI). Hypothesis: White matter damage is less severe in xenon treated patients, i.e. global
fractional anisotropy is significantly higher in the xenon group than in the control group as
assessed with the 1st magnetic resonance imaging (MRI).
After confirmation of aSAH and obtaining a signed assent subjects will be randomized to the
following groups:
Control group: Standard of Care (SOC) group: Air/oxygen and Normothermia 36.5-37.5°C; Xenon
group: Normothermia 36.5-37.5°C +Xenon inhalation in air/oxygen for 24 hours. Brain magnetic
resonance imaging techniques will be undertaken to evaluate the effects of the intervention
on white and grey matter damage and neuronal loss. Neurological outcome will be evaluated at
3, 12 and 24 months after onset of aSAH symptoms Investigational drug/treatment, dose and
mode of administration: 50±2 % end tidal concentration of inhaled xenon in oxygen/air.
Comparative drug(s)/placebo/treatment, dose and mode of administration: Standard of care
treatment according to local and international consensus reports.
Duration of treatment: 24 hours
Assessments:
Baseline data Information that characterizes the participant's condition prior to initiation
of experimental treatment is obtained as soon as is clinically reasonable. These include
participant demographics, medical history, vital signs, oxygen saturation, and concentration
of oxygen administered.
Acute data The collected information will contain quantitative and qualitative data of aSAH
patients, as recommended by recent recommendations of the working group on subject
characteristics, and including all relevant Common Data Elements (CDE) can be applied.
Specific definitions, measurements tools, and references regarding each SAH CDE can be found
on the weblink here:
https://www.commondataelements.ninds.nih.gov/SAH.aspx#tab=Data_Standards.