Brain Imaging After Non-traumatic Intracranial Hemorrhage (SAVEBRAINPWI)

Sponsor
Erasme University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05276934
Collaborator
(none)
100
1
46.2
2.2

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
  • Diagnostic Test: Brain computed tomography

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

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Assessment of Brain Imaging After Aneurysmal of AVM-related Intracranial Hemorrhage
Actual Study Start Date :
Feb 14, 2022
Anticipated Primary Completion Date :
Oct 20, 2025
Anticipated Study Completion Date :
Dec 20, 2025

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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)

  7. Change in the monitoring of tissue oxygen pressure (PtiO2) [Change between day 0, 5, 9 after Intracranial Hemorrhage]

    Monitoring of tissue oxygen pressure (PtiO2)

  8. 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

  9. 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)

  10. 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

  11. 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

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
  1. 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.

  1. Exclusion Criteria
  1. Traumatic intracranial hemorrhage

  2. Contra-indication to imaging or patient's refusal.

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT05276934
Other Study ID Numbers:
  • SRB2021298
First Posted:
Mar 14, 2022
Last Update Posted:
Mar 14, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2022