Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04696523
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-19
First Post:
2021-01-02
Brief Title:
Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage
Sponsor:
Turku University Hospital
Organization:
Turku University Hospital
Study Overview
Official Title:
Effect of Xenon on Brain Injury Neurological Outcome and Survival in Patients After Aneurysmal Subarachnoid Hemorrhage
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Xe-SAH
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 fractional anisotropy of white matter of diffusion tensor imaging DTI Hypothesis White matter damage is less severe in xenon treated patients ie 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 Airoxygen and Normothermia 365-375C Xenon group Normothermia 365-375C Xenon inhalation in airoxygen 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 drugtreatment dose and mode of administration 502 end tidal concentration of inhaled xenon in oxygenair
Comparative drugsplacebotreatment 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 participants 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 httpswwwcommondataelementsnindsnihgovSAHaspxtabData_Standards
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 ie 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 Airoxygen and Normothermia 365-375C Xenon group Normothermia 365-375C Xenon inhalation in airoxygen 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 drugtreatment dose and mode of administration 502 end tidal concentration of inhaled xenon in oxygenair
Comparative drugsplacebotreatment 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 participants 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 httpswwwcommondataelementsnindsnihgovSAHaspxtabData_Standards
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 arrival and whenever clinically indicated
2 1st 3 Tesla MRI 72 24 hours after onset of aSAH symptoms 2nd 3 Tesla MRI 42 4 days after onset of aSAH symptoms
3 3D DSA Computational fluid dynamic simulations CFD artificial intelligence and machine learning
4 Brain Positron emission tomography PET The 1st 4 1 weeks and the 2nd at 3 months after onset of aSAH symptoms
5 Biochemical assessment A blood samples of 20 ml for determination of plasma catecholamines plasma metabolomics see details of metabolomics in section 1847 cardiac enzyme release P-hs-troponin-T and heart fatty-acid binding protein selected biomarkers will be analysed at intensive crae unit ICU arrival and at 24h at 48h and at 72h after onset of SAH symptoms In addition a sample of spinal fluid will be collected through external ventricular drainage EVD at ICU arrival or as soon as it is in place and at 24h at 48h and at 72h after onset of SAH symptoms for assessment of metabolomics
6 Electrocardiograph ECG at ICU arrival and at 24h at 48h and at 72h after onset of aSAH symptoms
7 Neurological evaluation at 3 12 and at 24 months after aSAH with GOSe Modified ranking score mRS
Statistical methods 1 Basic statistical tests t-tests Mann-Whitney Chi square etc 2 Survival analysis methods 3 An analysis of variance for repeated measurements 4 A sample size of 100 is estimated on the basis of a recent studies in SAH patients to provide 80 power with a 2-sided α level of 005 to detect a mean difference of 002 SD 0035 in the global fractional anisotropy of white matter between the xenon group and the control group 98 Accordingly this mean difference is estimated to have a predictive value for DCI and poor neurological outcome ie mRS 3-6Significance level of 005 and an estimation of 95 confidence intervals will be used in the statistical analyses
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 arrival and whenever clinically indicated
2 1st 3 Tesla MRI 72 24 hours after onset of aSAH symptoms 2nd 3 Tesla MRI 42 4 days after onset of aSAH symptoms
3 3D DSA Computational fluid dynamic simulations CFD artificial intelligence and machine learning
4 Brain Positron emission tomography PET The 1st 4 1 weeks and the 2nd at 3 months after onset of aSAH symptoms
5 Biochemical assessment A blood samples of 20 ml for determination of plasma catecholamines plasma metabolomics see details of metabolomics in section 1847 cardiac enzyme release P-hs-troponin-T and heart fatty-acid binding protein selected biomarkers will be analysed at intensive crae unit ICU arrival and at 24h at 48h and at 72h after onset of SAH symptoms In addition a sample of spinal fluid will be collected through external ventricular drainage EVD at ICU arrival or as soon as it is in place and at 24h at 48h and at 72h after onset of SAH symptoms for assessment of metabolomics
6 Electrocardiograph ECG at ICU arrival and at 24h at 48h and at 72h after onset of aSAH symptoms
7 Neurological evaluation at 3 12 and at 24 months after aSAH with GOSe Modified ranking score mRS
Statistical methods 1 Basic statistical tests t-tests Mann-Whitney Chi square etc 2 Survival analysis methods 3 An analysis of variance for repeated measurements 4 A sample size of 100 is estimated on the basis of a recent studies in SAH patients to provide 80 power with a 2-sided α level of 005 to detect a mean difference of 002 SD 0035 in the global fractional anisotropy of white matter between the xenon group and the control group 98 Accordingly this mean difference is estimated to have a predictive value for DCI and poor neurological outcome ie mRS 3-6Significance level of 005 and an estimation of 95 confidence intervals will be used in the statistical analyses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-001542-17 | EUDRACT_NUMBER | None | None |