An observational study in Aneurysm, Ruptured, Aneurysmal Subarachnoid Hemorrhage and Arteriovenous Malformations, sponsored by Erasme University Hospital. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-02-21.
Sponsored by Erasme University Hospital · Observational
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
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.
29 studies on the registry are indexed under Aneurysm, Ruptured; 7 are open to participants now.
This study's planned enrollment of 100 is below the median of 183 across 12 observational studies indexed under Aneurysm, Ruptured.
Browse Aneurysm, Ruptured studies →Erasme University Hospital is the lead sponsor of 181 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
i. Inclusion Criteria
ii. Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Time frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Change in vessel size
Change in the vessel size measured on digital subtraction angiography (DSA) and computed tomography angiogram (CTA) in millimeters
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Change in the monitoring of tissue oxygen pressure (PtiO2)
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
Number of new ischemic lesions on non-contrast CT scan
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Plan to share: No — No data sharing
No publications or documents are linked to this record.
Started Mar 2022 (actual). Primary completion is estimated for Oct 2025, 43 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.