Status:
RECRUITING
Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage
Lead Sponsor:
Turku University Hospital
Collaborating Sponsors:
Academy of Finland
Conditions:
Subarachnoid Hemorrhage, Aneurysmal
Cerebral Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
An investigator-initiated clinical drug study Main Objective: To explore neuroprotective properties of xenon in patients after aneurysmal subarachnoid hemorrhage (SAH). Primary endpoint: Global fra...
Detailed Description
Assessments of efficacy: 1. A brain Computer tomography angiography (CTA) and / or 3 D Digital subtraction angiography (DSA) (whenever possible instead of 2D DSA) will be performed at hospital arriva...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04696523
Start Date
April 22 2025
End Date
December 31 2029
Last Update
May 1 2025
Active Locations (7)
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1
Aalto University School of Science
Helsinki, Helsinki, Finland
2
Kuopio University Hospital
Kuopio, Kuopio, Finland
3
Tampere University Hospital
Tampere, Pirkanmaa, Finland
4
Turku University Hospital
Turku, Turku, Finland, 20521