Aneurysm, RupturedSAVEBRAINPWINCT05276934
Brain Imaging After Non-traumatic Intracranial Hemorrhage (SAVEBRAINPWI)
An observational study of Aneurysm, Ruptured and Aneurysmal Subarachnoid Hemorrhage, run by Erasme University Hospital at 1 site in Belgium.
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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aneurysm, Ruptured, Aneurysmal Subarachnoid Hemorrhage, Arteriovenous Malformations
- What is being tested?
- Brain computed tomography
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2022to 20 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
- Inclusion Criteria
- 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. ii. Exclusion Criteria
- Traumatic intracranial hemorrhage
- Contra-indication to imaging or patient's refusal.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Erasme Hospital
Brussels, 1070
CUB-Hôpital Erasme Service de la Recherche biomédicale, +32 (0) 2 555 83 51, Service.Rech-biomed@erasme.ulb.ac.be
Boris Lubicz, MD, PhD, 003225553998, Boris.Lubicz@erasme.ulb.ac.be
About this study
Official title: 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
Read the 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.
- Conditions
- Aneurysm, Ruptured, Aneurysmal Subarachnoid Hemorrhage, Arteriovenous Malformations, Intracranial Aneurysm, Intracranial Hemorrhages
- Being tested
- Brain computed tomography
- Medical subject headings
- Aneurysm, Ruptured, Subarachnoid Hemorrhage, Arteriovenous Malformations, Intracranial Aneurysm, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain computed tomographyDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Brain computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change between day 0, 5, 9 after Intracranial Hemorrhage
Secondary outcomes (11)
Change in vessel size
Change in the vessel size measured on digital subtraction angiography (DSA) and computed tomography angiogram (CTA) in millimeters
Measured: Change between day 0, 5, 9 after Intracranial Hemorrhage
Time to next endovascular intervention for vasospastic stenosis
Delay between two procedures for the same indication
Measured: Number of days after the endovascular procedure until the next procedure in days, up to 4 weeks
Transcranial Doppler
Reduction in intracranial vasospasm assessed by the targeted vessel velocity in meters per second
Measured: 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
Measured: 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)
Measured: 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)
Measured: Change between day 0, 5, 9 after Intracranial Hemorrhage
Change in the monitoring of tissue oxygen pressure (PtiO2)
Monitoring of tissue oxygen pressure (PtiO2)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Change between day 0, 5, 9 after Intracranial Hemorrhage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Mar 2022
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm, RupturedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrien Guenego, MD, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276934
- Sponsor's protocol ID
- SRB2021298
- Acronym
- SAVEBRAINPWI
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2022
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data sharing
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Brain Imaging After Aneurysmal of AVM-related Intracranial Hemorrhage
- ClinicalTrials.gov ID
- NCT05276934
- Acronym / sponsor ID
- SAVEBRAINPWI / SRB2021298
- Conditions
- Aneurysm, Ruptured, Aneurysmal Subarachnoid Hemorrhage, Arteriovenous Malformations, Intracranial Aneurysm, Intracranial Hemorrhages
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evolution of brain imaging in Non-traumatic Intracranial Hemorrhage | – | Diagnostic Test: Brain computed tomographyThis 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain computed tomographyThis 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 | Diagnostic test | Evolution of brain imaging in Non-traumatic Intracranial Hemorrhage |
Primary outcome
Change in brain hypoperfusion
Time frame: 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
11 secondary outcomes
Change in vessel size
Time frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Time to next endovascular intervention for vasospastic stenosis
Time frame: Number of days after the endovascular procedure until the next procedure in days, up to 4 weeks
Transcranial Doppler
Time frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Brain Hypoperfusion 2
Time frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Change in Glasgow coma scale
Time frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Change in National Institutes of Health Stroke Scale score
Time frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Change in the monitoring of tissue oxygen pressure (PtiO2)
Time frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Change in the number of new ischemic lesions
Time frame: Change between day 0, 5, 9, 21 after Intracranial Hemorrhage
modified Rankin Scale at 3 months
Time frame: 3 months after Intracranial Hemorrhage
Change in brain hypoperfusion 3
Time frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Change in brain hypoperfusion 4
Time frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No. No data sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrien Guenego, MD principal investigator
Erasme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm, Ruptured and Aneurysmal Subarachnoid Hemorrhage, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Comite ethique hopital Erasme (003225553707, comite.ethique@erasme.ulb.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain hypoperfusion (time frame: Change between day 0, 5, 9 after Intracranial Hemorrhage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.