Effect of Inhaled Xenon on Cerebral White Matter Damage in Comatose Survivors of Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial.
Ruut Laitio, Marja Hynninen, Olli Arola...
https://pubmed.ncbi.nlm.nih.gov/26978207Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID04696523
Effect of Xenon on Brain Injury, Neurological Outcome and Survival in Patients After Aneurysmal Subarachnoid Hemorrhage
Led by Turku University Hospital · Updated on 2025-05-01
160
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Turku University Hospital
Lead Sponsor
A
Academy of Finland
Collaborating Sponsor
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 air/oxygen and normal body temperature, and the xenon group receiving inhaled xenon gas at a concentration of 50% mixed with air/oxygen 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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 7 locations
1
Aalto University School of Science
Helsinki, Helsinki, Finland
Not Yet Recruiting
2
Kuopio University Hospital
Kuopio, Kuopio, Finland
Not Yet Recruiting
3
Tampere University Hospital
Tampere, Pirkanmaa, Finland
Not Yet Recruiting
4
Turku University Hospital
Turku, Turku, Finland, 20521
Actively Recruiting
5
Elomatic
Turku, Turku, Finland, 20810
Not Yet Recruiting
6
University of Turku, Turku Bioscience, Analysis of the metabolomics
Turku, Turku, Finland
Not Yet Recruiting
7
Örebro University
Örebro, Örebro County, Sweden
Not Yet Recruiting
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Research Team
T
Timo T Laitio, MD, PhD
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
Inhaled Xenon Attenuates Myocardial Damage in Comatose Survivors of Out-of-Hospital Cardiac Arrest: The Xe-Hypotheca Trial.
Olli Arola, Antti Saraste, Ruut Laitio...
https://pubmed.ncbi.nlm.nih.gov/29169472Effect of xenon on brain injury, neurological outcome, and survival in patients after aneurysmal subarachnoid hemorrhage-study protocol for a randomized clinical trial.
Mikael Laaksonen, Jaakko Rinne, Melissa Rahi...
https://pubmed.ncbi.nlm.nih.gov/37337295