Testing xenon gas for brain injury after a ruptured brain aneurysm
Tests inhaled xenon gas in adults after a bleed from a brain aneurysm.
Plain-language title generated from the registry record
Registry title: Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage
Key facts
- Where
- Helsinki, Kuopio, Tampere, and Turku, FinlandSee the 6 sites
- Phase
- Phase 2
Where in Finland
- Aalto University School of ScienceHelsinki, FinlandNot yet recruiting
- Kuopio University HospitalKuopio, FinlandNot yet recruiting
- Tampere University HospitalTampere, FinlandNot yet recruiting
- ElomaticTurku, FinlandNot yet recruiting
- Turku University HospitalTurku, FinlandTaking people
- University of Turku, Turku Bioscience, Analysis of the metabolomicsTurku, FinlandNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Turku University Hospital
- Trial code
- NCT04696523
- Record updated
- 1 May 2025
- Original description
An investigator-initiated clinical drug studyRead full original descriptionShow less
Effect of Xenon on Brain Injury, Neurological Outcome and Survival in Patients After Aneurysmal Subarachnoid Hemorrhage
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.
Inclusion: 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.
Exclusion: Presence of implants or foreign bodies which are not known to be MRI safe; Maximum diameter of intracerebral hemorrhage > 2.5 cm; Neurological deficiency due to traumatic brain injury or other neurological illness; Imminent death or current life-threatening disease; 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; An aSAH subject may not be enrolled in the trial if he/she meets any one of the exclusion criteria below:; Acute or chronic traumatic brain injury; Pneumothorax or pneumomediastinum,; Acute lung injury requiring ≥ 60% FIO2 (fraction of inspired oxygen); Systolic arterial pressure < 80 mmHg or mean arterial pressure < 60 mmHg for over 30 min period; Bilaterally fixed and dilated pupils; Positive pregnancy test, known pregnancy, or current breast-feeding; Current enrollment in another interventional study.