Study of Xenon Treatment to Protect the Brain and Improve Recovery After Aneurysmal Subarachnoid Hemorrhage
Led by Turku University Hospital · Updated on 2025-05-01
160
Participants Needed
7
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the neuroprotective effects of xenon gas in patients who have experienced an aneurysmal subarachnoid hemorrhage aSAH, a type of brain bleed. The study aims to compare brain white matter damage between patients treated with xenon and those receiving standard care. The main goal is to see if xenon can reduce brain injury as measured by advanced MRI imaging within the first 48 to 96 hours after the hemorrhage.
Participants will be randomly assigned to one of two groups the control group receiving standard care with airoxygen and normal body temperature, and the xenon group receiving inhaled xenon gas at a concentration of 50% mixed with airoxygen alongside standard care. The xenon treatment will last for 24 hours. Various brain imaging techniques such as CT angiography, MRI, and PET scans will be used to monitor brain injury and recovery over time. Blood and spinal fluid samples will also be collected to study biomarkers related to brain stress and injury.
During the study, participants will undergo neurological evaluations at 3, 12, and 24 months after their hemorrhage to assess long-term outcomes. Researchers will also measure brain pressure, cardiac function, and biochemical markers during the initial intensive care period. The study includes a total follow-up of up to 2 years to evaluate the safety and effectiveness of xenon treatment compared to standard care in protecting the brain after aSAH.
CONDITIONS
Brief Title
Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage
Research Team
T
Timo T Laitio, MD, PhD
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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 grade 3 to 5
Age 18 years or older
Currently intubated
Glasgow Coma Scale score between 3 and 12 without neuromuscular blocking agents
Xenon treatment can be started within 6 hours after onset of SAH symptoms
You will not qualify if you...
Acute or chronic traumatic brain injury
Intracerebral hemorrhage larger than 2.5 cm in diameter
Pneumothorax or pneumomediastinum
Acute lung injury requiring 60% or more oxygen
Low blood pressure (systolic < 80 mmHg or mean arterial < 60 mmHg) lasting over 30 minutes
Bilaterally fixed and dilated pupils
Pregnancy, positive pregnancy test, or breastfeeding
Neurological problems caused by traumatic brain injury or other neurological illness
Imminent death or life-threatening disease
Currently enrolled in another interventional study
Clinically significant lab abnormalities, severe liver disease, severe lung disease, or social circumstances making participation inappropriate
Presence of implants or foreign bodies not safe for MRI
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 hours after onset of symptoms with ICU stay up to 14 days
Participants receive xenon inhalation or air/oxygen treatment in addition to standard care following aneurysmal subarachnoid hemorrhage.
Visits during ICU stay including assessments at ICU arrival and at 24h, 48h, and 72h after onset of symptoms
Follow-up
Duration - Up to 2 years after symptom onset
Participants undergo neurological evaluations and imaging assessments to monitor brain injury and neurological outcomes.
Multiple visits at 3 months, 12 months, and 24 months for neurological evaluations and imaging
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Effect of xenon on brain injury, neurological outcome, and survival in patients after aneurysmal subarachnoid hemorrhage-study protocol for a randomized clinical trial.