Brain Imaging After Non-traumatic Intracranial Hemorrhage (SAVEBRAINPWI) (SAVEBRAINPWI)

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

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

Study Overview

• Status: Recruiting
• Conditions: Arteriovenous Malformations; Intracranial Hemorrhages; Aneurysmal Subarachnoid Hemorrhage; Intracranial Aneurysm; Aneurysm, Ruptured
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Comite ethique hopital Erasme; Phone Number: 003225553707; Email: comite.ethique@erasme.ulb.ac.be
• Study Contact Backup: Name: Boris Lubicz, MD, PhD; Phone Number: 003225553998; Email: Boris.Lubicz@erasme.ulb.ac.be

Study Locations

• Belgium
  • Brussel, Belgium, 1070
    • Recruiting
    • Erasme hospital
    • Principal Investigator: Adrien Guenego, MD
    • Contact: Boris Lubicz, MD, PhD; Phone Number: 003225553998; Email: Boris.Lubicz@erasme.ulb.ac.be
    • Contact: CUB-Hôpital Erasme Service de la Recherche biomédicale; Phone Number: +32 (0) 2 555 83 51; Email: Service.Rech-biomed@erasme.ulb.ac.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who fit the inclusion criteria (suffered a non-traumatic (aneurysmal, AVM-related, unknown cause) intracranial hemorrhage) will be included prospectively.

The deadline for data collection November, 2031 Data analysis will be performed when judged necessary by the investigators.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

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
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
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
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

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Principal Investigator: Adrien Guenego, MD, Erasme University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): October 20, 2025
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Intracranial Arterial Diseases; Hemorrhage; Arteriovenous Malformations; Intracranial Hemorrhages; Aneurysm; Subarachnoid Hemorrhage; Intracranial Aneurysm; Aneurysm, Ruptured
• Other Study ID Numbers: SRB2021298

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No data sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No