Brain Imaging After Non-traumatic Intracranial Hemorrhage (SAVEBRAINPWI)

NCT05276934 | Recruiting

• 1 other identifier: SRB2021298
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in vessel size

  Change between day 0, 5, 9 after Intracranial Hemorrhage

• 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

• Transcranial Doppler

  Change between day 0, 5, 9 after Intracranial Hemorrhage

• Brain Hypoperfusion 2

  Change between day 0, 5, 9 after Intracranial Hemorrhage

• Change in Glasgow coma scale

  Change between day 0, 5, 9 after Intracranial Hemorrhage

Study Arms (1)

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

Interventions

Brain computed tomography DIAGNOSTIC_TEST

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

Evolution of brain imaging in Non-traumatic Intracranial Hemorrhage

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Traumatic intracranial hemorrhage
• Contra-indication to imaging or patient's refusal.

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

RECRUITING

MeSH Terms

Conditions

Aneurysm, Ruptured; Subarachnoid Hemorrhage; Arteriovenous Malformations; Intracranial Aneurysm; Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Intracranial Arterial Diseases

Study Officials

• Adrien Guenego, MD

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Comite ethique hopital Erasme

CONTACT

003225553707; comite.ethique@erasme.ulb.ac.be

Boris Lubicz, MD, PhD

CONTACT

003225553998; Boris.Lubicz@erasme.ulb.ac.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 14, 2022
• Study Start: March 1, 2022
• Primary Completion: October 20, 2025
• Study Completion: December 20, 2025
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)