Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage
Recruiting · NCT04696523 · Interventional (participants receive a specific treatment) · Lead sponsor: Turku University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
An investigator-initiated clinical drug study Main Objective: To explore neuroprotective properties of xenon in patients after aneurysmal subarachnoid hemorrhage (SAH). Primary endpoint: Global fractional anisotropy of white matter of diffusion tensor imaging (DTI). Hypothesis: White matter damage is less severe in xenon treated patients, i.e. global fractional anisotropy is significantly higher in the xenon group than in the control group as assessed with the 1st magnetic resonance imaging (MRI). After confirmation of aSAH and obtaining a signed assent subjects will be randomized to the following groups: Control group: Standard of Care (SOC) group: Air/oxygen and Normothermia 36.5-37.5°C; Xenon group: Normothermia 36.5-37.5°C +Xenon inhalation in air/oxygen for 24 hours. Brain magnetic resonance imaging techniques will be undertaken to evaluate the effects of the intervention on white and grey matter damage and neuronal loss. Neurological outcome will be evaluated at 3, 12 and 24 months after onset of aSAH symptoms Investigational drug/treatment, dose and mode of administration: 50±2 % end tidal concentration of inhaled xenon in oxygen/air. Comparative drug(s)/placebo/treatment, dose and mode of administration: Standard of care treatment according to local and international consensus reports. Duration of treatment: 24 hours Assessments: Baseline data Information that characterizes the participant's condition prior to initiation of experimental treatment is obtained as soon as is clinically reasonable. These include participant demographics, medical history, vital signs, oxygen saturation, and concentration of oxygen administered. Acute data The collected information will contain quantitative and qualitative data of aSAH patients, as recommended by recent recommendations of the working group on subject characteristics, and including all relevant Common Data Elements (CDE) can be applied. Specific definitions, measurements tools, and references regarding each SAH CDE can be found on the weblink here: https://www.commondataelements.ninds.nih.gov/SAH.aspx#tab=Data\_Standards.
Who can take part
Inclusion criteria
- To be considered eligible to participate in this study, a SAH subject must meet the inclusion criteria listed below:
- 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 3-5
- Age of ≥ 18 years
- Intubated.
- GCS 3-12 obtained off neuromuscular blocking agents
- 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:
- Acute or chronic traumatic brain injury
- Maximum diameter of intracerebral hemorrhage \> 2.5 cm
- Pneumothorax or pneumomediastinum,
- Acute lung injury requiring ≥ 60% FIO2 (fraction of inspired oxygen).
- Systolic arterial pressure \< 80 mmHg or mean arterial pressure \< 60 mmHg for over 30 min period
- Bilaterally fixed and dilated pupils
- Positive pregnancy test, known pregnancy, or current breast-feeding
- Neurological deficiency due to traumatic brain injury or other neurological illness
- Imminent death or current life-threatening disease
- Current enrollment in another interventional study
- 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.
- Presence of implants or foreign bodies which are not known to be MRI safe
Where it is running
7 locations listed.
- Aalto University School of Science - Helsinki, Helsinki, Finland
- Kuopio University Hospital - Kuopio, Kuopio, Finland
- Tampere University Hospital - Tampere, Pirkanmaa, Finland
- Turku University Hospital - Turku, Turku, Finland
- Elomatic - Turku, Turku, Finland
- University of Turku, Turku Bioscience, Analysis of the metabolomics - Turku, Turku, Finland
- Örebro University - Örebro, Örebro County, Sweden