Brain Imaging After Non-traumatic Intracranial Hemorrhage (SAVEBRAINPWI)

Intracranial Aneurysm Clinical Trial

— SAVEBRAINPWI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05276934
• Other study ID #: SRB2021298
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: December 20, 2025

Study information

• Verified date: February 2024
• Source: Erasme University Hospital
• Contact: Comite ethique hopital Erasme
• Phone: 003225553707
• Email: comite.ethique[@]erasme.ulb.ac.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 20, 2025
• Est. primary completion date: October 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Ruptured
• Aneurysmal Subarachnoid Hemorrhage
• Arteriovenous Malformations
• Hemorrhage
• Intracranial Aneurysm
• Intracranial Hemorrhages
• Subarachnoid Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in the monitoring of tissue oxygen pressure (PtiO2)	Monitoring of tissue oxygen pressure (PtiO2)	Change between day 0, 5, 9 after Intracranial Hemorrhage
Secondary	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
Secondary	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
Secondary	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
Secondary	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