Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage

NCT04696523 · tracked via the Priya Life Science Sweden tracker

Sponsor

Turku University Hospital

Phase

Phase 2

Started

2025-04-22

Last updated

2025-05-01

Condition(s) studied

Subarachnoid Hemorrhage, AneurysmalCerebral InjuryCerebral IschemiaCerebral InfarctionCardiac EventCardiac Failure

Investigational drug(s) / intervention(s)

Xenon →air/oxygen

Xenon: Xenon arm will be treated with xenon inhalation with endtidal concentration of 50 % in air/oxygen and with standard of care

air/oxygen: Control group will be treated with air/oxygen

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: To be considered eligible to participate in this study, a SAH subject must meet the inclusion criteria listed below: 1. Informed consent obtained from the next of kin or legal representative 2. Aneurysmal subarachnoid hemorrhage visible on CTA or DSA. 3. Deterioration of consciousness to Hunt-Hess 3-5 4. Age of ≥ 18 years 5. Intubated. 6. GCS 3-12 obtained off neuromuscular blocking agents 7. Xenon treatment can be started within 6 hours after onset of SAH symptoms Exclusion Criteria: An aSAH subject may not be enrolled in the trial if he/she meets any one of the exclusion criteria below: 1. Acute or chronic traumatic brain injury 2. Maximum diameter of intracerebral hemorrhage \> 2.5 cm 3. Pneumothorax or pneumomediastinum, 4. Acute lung injury requiring ≥ 60% FIO2 (fraction of inspired oxygen). 5. Systolic arterial pressure \< 80 mmHg or mean arterial pressure \< 60 mmHg for over 30 min period 6. Bilaterally fixed and dilated pupils 7. Positive pregnancy test, known pregnancy, or current breast-feeding 8. Neurological deficiency due to traumatic brain injury or other neurological illness 9. Imminent death or current life-threatening disease 10. Current enrollment in another interventional study 11. The subject is known to have clinically significant laboratory abnormality, medical condition (such as decompensated liver disease or severe chronic obstructive pulmonary disease), or social circumstance that, in the investigator's opinion, makes it inappropriate for the subject to participate in this clinical trial. 12. Presence of implants or foreign bodies which are not known to be MRI safe

Primary outcome measure(s)

Fractional anisotropy of the white matter — 48-96 hours after start of aSAH symptoms
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 MRI.

Trial sites (7)

Facility	City	Region	Status
Aalto University School of Science	Helsinki	Helsinki	Not Yet Recruiting
Kuopio University Hospital	Kuopio	Kuopio	Not Yet Recruiting
Tampere University Hospital	Tampere	Pirkanmaa	Not Yet Recruiting
Turku University Hospital	Turku	Turku	Recruiting
Elomatic	Turku	Turku	Not Yet Recruiting
University of Turku, Turku Bioscience, Analysis of the metabolomics	Turku	Turku	Not Yet Recruiting
Örebro University	Örebro	Örebro County	Not Yet Recruiting

More Turku University Hospital trials in Sweden

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04696523 on ClinicalTrials.gov ↗ ← All trials in Sweden