Using xenon to protect the brain after aneurysmal subarachnoid hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the neuroprotective effects of xenon inhalation in patients who have experienced an aneurysmal subarachnoid hemorrhage (SAH). Participants will be randomized into two groups: one receiving standard care and the other receiving standard care plus xenon inhalation for 24 hours. The primary endpoint is to assess white matter damage using diffusion tensor imaging (DTI) through MRI scans conducted at specified intervals. Additional assessments will include brain imaging techniques, biochemical evaluations, and neurological outcomes over a period of 24 months.

Why it matters

Who can join: the full rules

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

Where it's running

• Turku University Hospital
  Turku, Turku, Finland Recruiting
• Aalto University School of Science
  Helsinki, Helsinki, Finland Not yet recruiting
• Kuopio University Hospital
  Kuopio, Kuopio, Finland Not yet recruiting
• Tampere University Hospital
  Tampere, Pirkanmaa, Finland Not yet recruiting
• Elomatic
  Turku, Turku, Finland Not yet recruiting
• University of Turku, Turku Bioscience, Analysis of the metabolomics
  Turku, Turku, Finland Not yet recruiting

Study contacts

• Principal investigator: Timo T Laitio, MD, PhD — Turku University Hospital and University of Turku, Turku , Finland
• Study coordinator: Timo T Laitio, MD, PhD
• Email: timo.laitio@tyks.fi
• Phone: +358504653201

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.