Brain Imaging After Non-traumatic Intracranial Hemorrhage (SAVEBRAINPWI)

Study Overview
=================
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

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.

Official Title
-----------------
Prospective Assessment of Brain Imaging After Aneurysmal of AVM-related Intracranial Hemorrhage

Conditions
-----------------
Aneurysm, Ruptured, Aneurysmal Subarachnoid Hemorrhage, Arteriovenous Malformations, Intracranial Aneurysm, Intracranial Hemorrhages

Intervention / Treatment
-----------------
* Diagnostic Test: Brain computed tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
i. Inclusion Criteria Age ≥ 18 years Non-traumatic intracranial hemorrhage (subarachnoid hemorrhage secondary to a ruptured aneurysm or AVM, unknown cause, per procedural bleed) In case of ruptured aneurysm, AVM or other etiology : need to be secured with surgical clipping or endovascular intervention if judged possible No contra-indication to perfusion imaging Subject or legal representative is able and willing to give informed consent. ii. Exclusion Criteria Traumatic intracranial hemorrhage Contra-indication to imaging or patient's refusal.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Evolution of brain imaging in Non-traumatic Intracranial Hemorrhage<br>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<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in brain hypoperfusion | Brain hypoperfusion in arterial territories assessed by the delays on perfusion Time to drain (seconds) on CT and/or MR perfusion | Change between day 0, 5, 9 after Intracranial Hemorrhage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vessel size | Change in the vessel size measured on digital subtraction angiography (DSA) and computed tomography angiogram (CTA) in millimeters | Change between day 0, 5, 9 after Intracranial Hemorrhage | 
| Time to next endovascular intervention for vasospastic stenosis | Delay between two procedures for the same indication | Number of days after the endovascular procedure until the next procedure in days, up to 4 weeks | 
| Transcranial Doppler | Reduction in intracranial vasospasm assessed by the targeted vessel velocity in meters per second | Change between day 0, 5, 9 after Intracranial Hemorrhage | 
| Brain Hypoperfusion 2 | Reduction in brain hypoperfusion assessed by the volumes on different perfusion parameters time to peak (in seconds) on CT and/or MR perfusion | Change between day 0, 5, 9 after Intracranial Hemorrhage | 
| Change in Glasgow coma scale | Glasgow coma scale (GCS between 3 and 15, a higher score means a better outcome) | Change between day 0, 5, 9 after Intracranial Hemorrhage | 
| Change in National Institutes of Health Stroke Scale score | National Institutes of Health Stroke Scale (NIHSS between 0 and 42, a higher score means a worse outcome) | Change between day 0, 5, 9 after Intracranial Hemorrhage | 
| Change in the monitoring of tissue oxygen pressure (PtiO2) | Monitoring of tissue oxygen pressure (PtiO2) | Change between day 0, 5, 9 after Intracranial Hemorrhage | 
| Change in the number of new ischemic lesions | Number of new ischemic lesions on non-contrast CT scan | Change between day 0, 5, 9, 21 after Intracranial Hemorrhage | 
| modified Rankin Scale at 3 months | clinical evolution (mRS between 0 and 6, a higher score means a worse outcome) | 3 months after Intracranial Hemorrhage | 
| Change in brain hypoperfusion 3 | Brain hypoperfusion in arterial territories assessed by the delays on perfusion parameters TMax maps in seconds on CT and/or MR perfusion | Change between day 0, 5, 9 after Intracranial Hemorrhage | 
| Change in brain hypoperfusion 4 | Brain hypoperfusion in arterial territories assessed by the delays on perfusion parameters Mean transit time on CT and/or MR perfusion in seconds | Change between day 0, 5, 9 after Intracranial Hemorrhage |