Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06793839

3D Contrast Enhanced Ultrasound Imaging to Study Early Brain Injury and Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage Using an Experimental Medical Device

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

15

Participants Needed

1

Research Sites

43 weeks

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 serious type of stroke with major complications including early brain injury, vasospasm, and delayed cerebral ischemia. These complications are typically monitored in neurocritical care settings using brain imaging methods like CT scans, MRI, and arteriography, which require moving critically ill patients within the hospital and can lead to complications. This research explores a new, non-invasive bedside device using 3D enhanced ultrasonography localizing microscopy to detect key arteries in the brain's anterior circulation, aiming to improve diagnosis and management of SAH complications. Participants with aneurysmal SAH involving the anterior circulation will receive standard care plus three bilateral transcranial enhanced ultrasonography exams using microbubble contrast (Sonovue) at three risk periods: days 0-2, 4-10, and 11-14. This investigational device is designed to provide detailed imaging comparable to angiography while being more accessible and safer by avoiding patient transport. The study plans to enroll 15 patients in a single-center feasibility pilot trial. During the study, researchers will assess the quality of blood flow signal captured by the ultrasonography through time-intensity curves of the contrast agent at each time point. They will also compare imaging findings with clinical outcomes. This bedside monitoring approach could allow earlier detection of complications like vasospasm or delayed ischemia without moving patients, potentially improving care. The trial includes assessments over two weeks and aims to gather initial data to support future larger studies.

CONDITIONS

Official 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 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.
Not Eligible

You will not qualify if you...

  • Non-aneurysmal subarachnoid hemorrhage.
  • 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 (S�e9curit�e9 Sociale)

AI-Screening

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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