NCT04696523 Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage
| NCT ID | NCT04696523 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Turku University Hospital |
| Condition | Subarachnoid Hemorrhage, Aneurysmal |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 160 participants in total. It began in 2025-04-22 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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
Contact & Investigator
Timo T Laitio, MD, PhD
PRINCIPAL INVESTIGATOR
Turku University Hospital and University of Turku, Turku , Finland
Frequently Asked Questions
Who can join the NCT04696523 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Subarachnoid Hemorrhage, Aneurysmal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04696523 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04696523 currently recruiting?
Yes, NCT04696523 is actively recruiting participants. Contact the research team at timo.laitio@tyks.fi for enrollment information.
Where is the NCT04696523 trial being conducted?
This trial is being conducted at Helsinki, Finland, Kuopio, Finland, Tampere, Finland, Turku, Finland and 3 additional locations.
Who is sponsoring the NCT04696523 clinical trial?
NCT04696523 is sponsored by Turku University Hospital. The principal investigator is Timo T Laitio, MD, PhD at Turku University Hospital and University of Turku, Turku , Finland. The trial plans to enroll 160 participants.