Clinical trial NCT06793839: 3D Contrast Enhanced Acoustic Perfusion Imaging in Adult After Subarachnoid Hemorrhage
Official title: Pilot Study : Characterization of Early Brain Injury and Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage by Ultrasound Localization Microscopy (ULM) 3D with an Experimental Medical Device (ESRIR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subarachnoid Hemorrhage
Keywords: aneurysmal
subarachnoid
hemorrhage
transcranial
doppler
ultrasonography
vasospasm
localizing
microscopy
delayed
cerebral
ischemia
aneurysm
anterior
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: European Research Council
First posted: 2025-01-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group of 15 patients with subarachnoïd hemorrhage
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Aneurysmal subarachnoid hemorrhage (SAH) is a devastating form of stroke, with three major complications : early brain injury (EBI), vasospasm and delayed cerebral ischemia (DCI). Those patients are often given care in neurocritical care. Imaging is particularly useful to diagnose these complications. Brain imaging includes CT scan, MRI and arteriography which are not easily available and need an intrahospital transportation. Furthermore, intrahospital transportation of critically ill patients is associated with significant complications Here, investigators try to show that a new non-invasive bedside device, based on 3D enhanced ultrasonography, is able to detect principal arteries of anterior circulation of the brain.

Detailed description: Introduction: Aneurysmal subarachnoid hemorrhage (SAH) is a devastating form of hemorrhagic stroke. Majors complications of aneurysmal SAH include early brain injury (EBI), vasospam and delayed cerebral ischemia (DCI). There are currently only few ways through imaging to diagnose those complication. Transcranial doppler (TCD) is an accessible bedside tool which is efficient, but can only provide indirect evidences. Other brain imaging includes CT scan, MRI and arteriography which are not easily available and are associated with intrahospital transportation of critically ill patients and its morbidity. There are several preclinical evidences that 3D enhanced ultrasonography localizing microscopy could show similar images resolution to angiography while being more accessible.

Materials and methods: this study will include patients with aneurysmal SAH. Aneurysm must be of anterior circulation.The investigators will perform a feasibility research with a new medical device based on ultrasonography localizing microscopy. The standard of care will not be changed, but each patient will also get three bilateral transcranial enhanced (with microbubbles from Sonovue) ultrasonography, one for each period at risk (J0-J2, J4-10, J11-J14). The primary outcome will be the quality of time-intensity curve of the contrast agent, in order to show the quality of signal received. Then, as a secondary outcome, images will be compared to clinical findings. As a pilot study, the investigators plan to include only 15 patients in a monocentric trial.

This device could provide real-time information on blood flow and potential complications such as vasospasm or DCI, allowing for earlier intervention and potentially improving outcomes for SAH patients. Additionally, the bedside nature of this device eliminates the need for intrahospital transportation, reducing the risk of complications associated with moving critically ill patients.

This study aims to assess the feasibility and potential benefits of using 3D enhanced ultrasonography localizing microscopy in the management of aneurysmal SAH. The results of this pilot study could pave the way for larger clinical trials and ultimately lead to improved outcomes for patients with this devastating condition.

Eligibility criteria: Inclusion Criteria:

* Admitted in neurologic ICU of the CHU Caen, Normandy, for a subarachnoid hemorrhage of the anterior circulation.
* Usable ultrasound temporal window.
* 18 years old and more.
* Consent of the participant or the trusted person.

Exclusion Criteria:

* non-aneurysmal subarachnoid haemorrhage.
* Contraindication to ultrasound contrast agent Sonovue, including allergies to a compound.
* Uncontrolled systemic hypertension.
* Acute respiratory distress syndrome.
* Pregnancy or breastfeeding mother.
* Vulnerable person with guardianship or curatorship.
* Patient not affiliated to french social security system (Sécurité Sociale)

Primary outcomes:
measure: Presence of a time-intensity curve (TIC) of contrast agent / Quality of signal
timeFrame: day 0-2 / day 4-10 / day 11-14
Secondary outcomes:
measure: Agreement between data from 3D ultrasonography localizing miroscopy and clinical parameters of early brain injury, cerebral vasospam and delayed cerebral ischemia
timeFrame: day 0-2 / day 4-10 / day 11-14
measure: Ability to detect principal arteries of anterior circulation
timeFrame: day 0-2 / day 4-10 / day 11-14
measure: Variability of measurement
timeFrame: day 0-2 / day 4-10 / day 11-14
Other outcomes:
Locations:
city: Caen
country: France
facility: CAEN University Hospital
Study officials:
affiliation: CHU CAEN
name: Clément GAKUBA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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