Using xenon to protect the brain after aneurysmal subarachnoid hemorrhage

Effect of Xenon on Brain Injury, Neurological Outcome and Survival in Patients After Aneurysmal Subarachnoid Hemorrhage

This study is testing if inhaling xenon gas can help protect the brains of people who have had a brain bleed from an aneurysm.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Turku University Hospital (other gov)
• Locations: 7 sites (Helsinki, Helsinki and 6 other locations)
• Trial ID: NCT04696523 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have suffered an aneurysmal subarachnoid hemorrhage and have a deterioration of consciousness.

Not a fit: Patients with acute or chronic traumatic brain injury or severe intracerebral hemorrhage may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce brain injury and improve neurological outcomes for patients after SAH.

How similar studies have performed: While the use of xenon for neuroprotection is a novel approach, similar studies have shown promise in other contexts, suggesting potential for success.

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

Where this trial is running

Helsinki, Helsinki and 6 other locations

• 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)
• Turku University Hospital — Turku, Turku, Finland (RECRUITING)
• Elomatic — Turku, Turku, Finland (NOT_YET_RECRUITING)
• University of Turku, Turku Bioscience, Analysis of the metabolomics — Turku, Turku, Finland (NOT_YET_RECRUITING)
• Örebro University — Örebro, Örebro County, Sweden (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

Conditions: Subarachnoid Hemorrhage, Aneurysmal, Cerebral Injury, Cerebral Ischemia, Cerebral Infarction, Cardiac Event, Cardiac Failure, xenon, neuroprotection, aneurysmal subarachnoid hemorrhage