Brain Imaging After Non-traumatic Intracranial Hemorrhage (SAVEBRAINPWI)
Study Details
Study Description
Brief Summary
The study is an observational prospective evaluation of an approved and unchanged clinical management, evaluating different diagnosis methods to assess brain perfusion in patients with an aneurysmal or AVM-related intracranial hemorrhage
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
The study is a prospective description and evaluation of an approved and unchanged clinical management, evaluating already used different diagnosis methods to assess brain perfusion in patients with atraumatic (aneurysmal, AVM-related, unknown cause) intracranial hemorrhage.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Evolution of brain imaging in Non-traumatic Intracranial Hemorrhage This study will use an established local protocol for DCI and intracranial arterial vasospastic stenosis screening, and follow-up to make sure that all patients have the same protocol and don't lose any chance of improvement and good outcome |
Diagnostic Test: Brain computed tomography
This study will use an established local protocol for DCI and intracranial arterial vasospastic stenosis screening, and follow-up to make sure that all patients have the same protocol and don't lose any chance of improvement and good outcome : CT perfusion at different time intervals
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Outcome Measures
Primary Outcome Measures
- Change in brain hypoperfusion [Change between day 0, 5, 9 after Intracranial Hemorrhage]
Brain hypoperfusion in arterial territories assessed by the delays on perfusion Time to drain (seconds) on CT and/or MR perfusion
Secondary Outcome Measures
- Change in vessel size [Change between day 0, 5, 9 after Intracranial Hemorrhage]
Change in the vessel size measured on digital subtraction angiography (DSA) and computed tomography angiogram (CTA) in millimeters
- Time to next endovascular intervention for vasospastic stenosis [Number of days after the endovascular procedure until the next procedure in days, up to 4 weeks]
Delay between two procedures for the same indication
- Transcranial Doppler [Change between day 0, 5, 9 after Intracranial Hemorrhage]
Reduction in intracranial vasospasm assessed by the targeted vessel velocity in meters per second
- Brain Hypoperfusion 2 [Change between day 0, 5, 9 after Intracranial Hemorrhage]
Reduction in brain hypoperfusion assessed by the volumes on different perfusion parameters time to peak (in seconds) on CT and/or MR perfusion
- Change in Glasgow coma scale [Change between day 0, 5, 9 after Intracranial Hemorrhage]
Glasgow coma scale (GCS between 3 and 15, a higher score means a better outcome)
- Change in National Institutes of Health Stroke Scale score [Change between day 0, 5, 9 after Intracranial Hemorrhage]
National Institutes of Health Stroke Scale (NIHSS between 0 and 42, a higher score means a worse outcome)
- Change in the monitoring of tissue oxygen pressure (PtiO2) [Change between day 0, 5, 9 after Intracranial Hemorrhage]
Monitoring of tissue oxygen pressure (PtiO2)
- Change in the number of new ischemic lesions [Change between day 0, 5, 9, 21 after Intracranial Hemorrhage]
Number of new ischemic lesions on non-contrast CT scan
- modified Rankin Scale at 3 months [3 months after Intracranial Hemorrhage]
clinical evolution (mRS between 0 and 6, a higher score means a worse outcome)
- Change in brain hypoperfusion 3 [Change between day 0, 5, 9 after Intracranial Hemorrhage]
Brain hypoperfusion in arterial territories assessed by the delays on perfusion parameters TMax maps in seconds on CT and/or MR perfusion
- Change in brain hypoperfusion 4 [Change between day 0, 5, 9 after Intracranial Hemorrhage]
Brain hypoperfusion in arterial territories assessed by the delays on perfusion parameters Mean transit time on CT and/or MR perfusion in seconds
Eligibility Criteria
Criteria
- Inclusion Criteria
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Age ≥ 18 years
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Non-traumatic intracranial hemorrhage (subarachnoid hemorrhage secondary to a ruptured aneurysm or AVM, unknown cause, per procedural bleed)
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In case of ruptured aneurysm, AVM or other etiology : need to be secured with surgical clipping or endovascular intervention if judged possible
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No contra-indication to perfusion imaging
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Subject or legal representative is able and willing to give informed consent.
- Exclusion Criteria
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Traumatic intracranial hemorrhage
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Contra-indication to imaging or patient's refusal.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Erasme Hospital | Brussel | Belgium | 1070 |
Sponsors and Collaborators
- Erasme University Hospital
Investigators
- Principal Investigator: Adrien Guenego, MD, Erasme University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SRB2021298