Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06793839

Pilot Study of 3D Ultrasound Localization Microscopy to Detect Brain Injury After Aneurysmal Subarachnoid Hemorrhage Using an Experimental Device

Led by University Hospital, Caen · Updated on 2025-01-27

15

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University Hospital, Caen

Lead Sponsor

E

European Research Council

Collaborating Sponsor

AI-Summary

What this Trial Is About

Aneurysmal subarachnoid hemorrhage (SAH) is a severe type of stroke that can cause early brain injury, vasospasm, and delayed cerebral ischemia. These complications are usually diagnosed using brain imaging techniques like CT scans, MRI, and arteriography, which require moving critically ill patients within the hospital, posing risks. This research aims to evaluate a new non-invasive bedside device using 3D enhanced ultrasonography to detect the main arteries in the brain's anterior circulation, potentially improving diagnosis without the need for transportation. Participants with aneurysmal SAH affecting the anterior circulation will undergo three bilateral transcranial enhanced ultrasonography scans using a device with microbubble contrast agent (Sonovue), performed at three key risk periods: days 0-2, 4-10, and 11-14. This pilot study will not alter standard care but will assess the quality of the imaging signal and compare findings with clinical outcomes. The study plans to include 15 patients at a single center. During the study, patients will receive the enhanced ultrasonography scans at bedside without moving to other hospital locations. Researchers will measure the presence and quality of the time-intensity curve from the contrast agent as the primary outcome. Secondary outcomes include comparing ultrasound data to clinical signs of brain injury and vasospasm, detecting principal arteries, and evaluating measurement consistency. The study will run until March 2025 and aims to assess feasibility and potential clinical benefits.

CONDITIONS

Brief Title

3D Contrast Enhanced Acoustic Perfusion Imaging in Adult After Subarachnoid Hemorrhage

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admitted in neurologic ICU for subarachnoid hemorrhage of the anterior circulation
  • Usable ultrasound temporal window
  • 18 years old and above
  • Consent given by participant or trusted person
Not Eligible

You will not qualify if you...

  • Non-aneurysmal subarachnoid hemorrhage
  • Allergy or contraindication to ultrasound contrast agent Sonovue
  • Uncontrolled systemic hypertension
  • Acute respiratory distress syndrome
  • Pregnancy or breastfeeding
  • Vulnerable person under guardianship or curatorship
  • Not affiliated with French social security system

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 14 days

Participants undergo three enhanced transcranial ultrasonography sessions using a new 3D ultrasound localization microscopy device to visualize cranial arteries and assess brain injury after subarachnoid hemorrhage.

3 visits (in-person) during days 0-2, 4-10, and 11-14

Trial Site Locations

Total: 1 location

1

CAEN University Hospital

Caen, France, 14000

Actively Recruiting

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Research Team

C

Clément GAKUBA, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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Published Research Related To This Trial

Ultrasound Perfusion Imaging for the Detection of Cerebral Hypoperfusion After Aneurysmal Subarachnoid Hemorrhage.

Christian Fung, Dieter Henrik Heiland, Raluca Reitmeir...

https://pubmed.ncbi.nlm.nih.gov/35211837