Effect of Xenon on Brain Injury, Neurological Outcome and Survival in Patients After Aneurysmal Subarachnoid Hemorrhage

Who is this study for? Patients with Cerebral Infarction, Cardiac Event
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ To be considered eligible to participate in this study, a SAH subject must meet the inclusion criteria listed below:

• Informed consent obtained from the next of kin or legal representative

• Aneurysmal subarachnoid hemorrhage visible on CTA or DSA.

• Deterioration of consciousness to Hunt-Hess 3-5

• Age of ≥ 18 years

• Intubated.

• GCS 3-12 obtained off neuromuscular blocking agents

• Xenon treatment can be started within 6 hours after onset of SAH symptoms

Locations
Other Locations
Finland
Aalto University School of Science
NOT_YET_RECRUITING
Helsinki
Kuopio University Hospital
NOT_YET_RECRUITING
Kuopio
Tampere University Hospital
NOT_YET_RECRUITING
Tampere
Elomatic
NOT_YET_RECRUITING
Turku
Turku University Hospital
RECRUITING
Turku
University of Turku, Turku Bioscience, Analysis of the metabolomics
NOT_YET_RECRUITING
Turku
Sweden
Örebro University
NOT_YET_RECRUITING
Örebro
Contact Information
Primary
Timo T Laitio, MD, PhD
timo.laitio@tyks.fi
+358504653201
Time Frame
Start Date: 2025-04-22
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 160
Treatments
Active_comparator: Air/Oxygen
Control arm: air/oxygen with standard of care
Experimental: xenon
Xenon arm: xenon inhalation in air/oxygen with standard of care
Sponsors
Collaborators: Academy of Finland
Leads: Turku University Hospital

This content was sourced from clinicaltrials.gov