Clinical trial NCT05276934: Brain Imaging After Non-traumatic Intracranial Hemorrhage (SAVEBRAINPWI)
Official title: Prospective Assessment of Brain Imaging After Aneurysmal of AVM-related Intracranial Hemorrhage
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aneurysm, Ruptured
Aneurysmal Subarachnoid Hemorrhage
Arteriovenous Malformations
Intracranial Aneurysm
Intracranial Hemorrhages
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in brain hypoperfusion
timeFrame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Secondary outcomes:
measure: Change in vessel size
timeFrame: Change between day 0, 5, 9 after Intracranial Hemorrhage
measure: Time to next endovascular intervention for vasospastic stenosis
timeFrame: Number of days after the endovascular procedure until the next procedure in days, up to 4 weeks
measure: Transcranial Doppler
timeFrame: Change between day 0, 5, 9 after Intracranial Hemorrhage
measure: Brain Hypoperfusion 2
timeFrame: Change between day 0, 5, 9 after Intracranial Hemorrhage
measure: Change in Glasgow coma scale
timeFrame: Change between day 0, 5, 9 after Intracranial Hemorrhage
measure: Change in National Institutes of Health Stroke Scale score
timeFrame: Change between day 0, 5, 9 after Intracranial Hemorrhage
measure: Change in the monitoring of tissue oxygen pressure (PtiO2)
timeFrame: Change between day 0, 5, 9 after Intracranial Hemorrhage
measure: Change in the number of new ischemic lesions
timeFrame: Change between day 0, 5, 9, 21 after Intracranial Hemorrhage
measure: modified Rankin Scale at 3 months
timeFrame: 3 months after Intracranial Hemorrhage
measure: Change in brain hypoperfusion 3
timeFrame: Change between day 0, 5, 9 after Intracranial Hemorrhage
measure: Change in brain hypoperfusion 4
timeFrame: Change between day 0, 5, 9 after Intracranial Hemorrhage
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Erasme Hospital
Study officials:
affiliation: Erasme University Hospital
name: Adrien Guenego, MD
role: PRINCIPAL_INVESTIGATOR
References: