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Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage

RecruitingPhase 2Ages 18 Years - anyAllTurku University Hospital
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In plain words

What the trial is, and whether it could suit you

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 wh

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📋 Eligibility rules (as published)
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
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What it tests

  • Xenon
  • air/oxygen
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Where

7 sites
Aalto University School of Science
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Elomatic
Turku, Finland
University of Turku, Turku Bioscience, Analysis of the metabolomics
Turku, Finland
Örebro University
Örebro, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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