No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
160 (estimated)
Sponsor
Turku University Hospital · Government
Who this trial is looking for
This trial is looking for patients who have suffered an aneurysmal subarachnoid hemorrhage (SAH). Participants will receive either standard care or xenon inhalation for 24 hours to see if it helps protect the brain.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with aneurysmal subarachnoid hemorrhage.
I am 18 years or older.
I have signed consent from my next of kin or legal representative.
My consciousness has deteriorated to a Hunt-Hess score of 3-5.
I am intubated.
I have a Glasgow Coma Scale (GCS) score of 3-12.
Xenon treatment can start within 6 hours after my SAH symptoms began.
You may not be able to join if
I have had a recent traumatic brain injury.
I have a large intracerebral hemorrhage over 2.5 cm.
I have pneumothorax or pneumomediastinum.
I need more than 60% oxygen support.
My blood pressure has been too low for over 30 minutes.
I have fixed and dilated pupils.
I am pregnant or breastfeeding.
I have a life-threatening illness.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 highe…
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.
Trial Locations
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Eligibility Criteria
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 consci…
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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