Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage

Launched by TURKU UNIVERSITY HOSPITAL · Jan 5, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a gas called xenon on patients who have suffered from a specific type of brain bleeding known as aneurysmal subarachnoid hemorrhage (aSAH). The main goal is to see if inhaling xenon can help protect the brain from damage after this serious condition. Patients who qualify for the study will be randomly assigned to one of two groups: one will receive standard medical care, while the other will receive standard care plus xenon inhalation for 24 hours. Researchers will use advanced imaging techniques to assess brain health and recovery over the following months.

To be eligible for this trial, participants must be at least 18 years old, have experienced aSAH confirmed by imaging tests, and show certain signs of reduced consciousness. They must also be intubated, meaning they require assistance to breathe. However, patients with certain serious conditions, like severe lung issues or major brain injuries, won't be able to participate. If someone is chosen for the trial, they can expect close monitoring and follow-up assessments to see how well they recover over time.

Gender

ALL

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