Ultrasound versus CT for measuring brain blood flow after subarachnoid hemorrhage
Prospective Monocentric Study Comparing Cerebral Perfusion Parameters From an ULtrasonic Imaging System With Measures Provided by Clinical Routine Perfusion CT
This will test whether contrast-enhanced bedside ultrasound can show brain blood flow as well as routine perfusion CT in adults in the neuro ICU with subarachnoid hemorrhage or other acute brain injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Resolve Stroke Industry-sponsored |
| Locations | 1 site (Montpellier, Herault) |
| Trial ID | NCT07324421 on ClinicalTrials.gov |
What this trial studies
The study gives a licensed ultrasound contrast agent (SonoVue®) at the bedside and acquires contrast-enhanced ultrasound (CEUS) perfusion images through the temporal window, generating time–intensity curves to quantify cerebral perfusion. Those CEUS measurements are then compared with routine perfusion CT (CTP) performed for clinical indication to see how well the two methods agree. Participants are adult ICU/CCU patients who need at least one CTP, and patients who cannot consent may be enrolled with relative consent per local rules. Safety monitoring focuses on contrast agent tolerance and hemodynamic stability during and after imaging.
Who should consider this trial
Good fit: Adults (≥18) admitted to the ICU/CCU who are scheduled for perfusion CT and are being monitored for complications such as delayed cerebral ischemia after subarachnoid hemorrhage, with consent provided by the patient or a relative.
Not a fit: Patients with contraindications to SonoVue (allergy, right-to-left shunt), temporal bone defects or recent temporal craniectomy or wounds, pregnant or breastfeeding women, or those with unstable hemodynamics are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, CEUS could provide a safe, bedside, repeatable way to detect cerebral perfusion problems sooner and reduce the need for patient transport and radiation exposure from repeated CT scans.
How similar studies have performed: Small observational studies and case series have shown promising correlation between CEUS perfusion measures and CT-based perfusion, but large prospective comparisons are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient ≥ 18 years old * Patient Informed Consent, or from his/her relative if the patient is not conscious and able to consent * Admission to ICU or CCU with indication to perform at least one CTP * Affiliated with or benefiting from a social security scheme * The subject's current clinical status, as assessed by medical history, physical examination, and/or relevant tests, indicates that they do not require immediate medical treatment or emergency care at the time of enrolment. Exclusion Criteria: * Guardianship, curatorship or any deprivation of liberty by judicial or administrative decision * Pregnant or breast-feeding women * Known contra-indication or hypersensitivity to SonoVue® (to sulfur hexafluoride microbubbles or to one of its excipients such as polyethylene glycol (PEG)) * Right-to-left shunts * Patients who have undergone craniectomy in the temporal region * Patients with open wounds or recent scars in the temporal region * Unstable hemodynamic or respiratory state contraindicating transportation to CTP scanner
Where this trial is running
Montpellier, Herault
- Centre Hospitalo-Universitaire Gui de Chauliac — Montpellier, Herault, France (Recruiting)
Study contacts
- Study coordinator: Vivien Szabo, MD, PHD
- Email: v-szabo@chu-montpellier.fr
- Phone: +33467336733
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.