Aneurysmal Subarachnoid Hemorrhage, Aneurysm, Ruptured, Arteriovenous Malformations, Intracranial Aneurysm, Intracranial Hemorrhages
Conditions
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.
Interventions
DIAGNOSTIC_TESTBrain 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
Sponsors
Erasme University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
i. Inclusion Criteria 1. Age ≥ 18 years 2. Non-traumatic intracranial hemorrhage (subarachnoid hemorrhage secondary to a ruptured aneurysm or AVM, unknown cause, per procedural bleed) 3. In case of ruptured aneurysm, AVM or other etiology : need to be secured with surgical clipping or endovascular intervention if judged possible 4. No contra-indication to perfusion imaging 5. Subject or legal representative is able and willing to give informed consent. ii.
Exclusion criteria
1. Traumatic intracranial hemorrhage 2. Contra-indication to imaging or patient's refusal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 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 |
| 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 |
Countries
Belgium
Contacts
Primary ContactComite ethique hopital Erasme
Backup ContactBoris Lubicz, MD, PhD
Outcome results
None listed