Cerebral HemorrhagePerCEUSNCT05893407
Brain PERfusion Evaluation by Contrast-Enhanced UltraSound
An observational study of Cerebral Hemorrhage and Subarachnoid Hemorrhage, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The objective of the study is to assess brain tissue perfusion by contrast-enhanced ultrasound perfusion imaging (PerCEUS) in acute brain injuries. More precisely, it aims : to evaluate the heterogeneity of brain perfusion and thus diagnose brain tissue hypoperfusion with contrast-enhanced ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Hemorrhage, Subarachnoid Hemorrhage, Ischemic Stroke
- What is being tested?
- Measuring contrast-enhanced ultrasound perfusion with phase inversion harmonic imaging
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2023to Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in neurosurgical intensive care in Lariboisière Hospital, Paris, with acute brain injuries
Who may be able to join
- Age ≥18
- Intensive care unit admission for acute brain injury
- Proven acute brain injury by CT and/or MRI
- Requiring a contrast ultrasound imaging
- Informed consent of patient or relative
Who cannot join
- Pregnancy
- Not sufficient temporal window
- Contraindications to Sonovue ® : acute coronary syndromes, severe ischemic heart disease (requiring revascularization), pulmonary arterial hypertension > 90 mmHg, right-left shunt, ARDS, dobutamine's use, known allergy or adverse reaction to Sonovue®
- Patient on State Medical Assistance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Lariboisière Hospital
Paris, 75010
Romain BARTHELEMY, MD, +33149958515, romain.barthelemy@aphp.fr
Benjamin Glenn CHOUSTERMAN, MD PhD, +33149958518, benjamin.chousterman@aphp.fr
About this study
Official title: Quantification of Cerebral Perfusion at the Patient's Bedside When Performing Contrast-enhanced Ultrasound in Neurointensive Care Patients
The objective of the study is to assess brain tissue perfusion by contrast-enhanced ultrasound perfusion imaging (PerCEUS) in acute brain injuries. More precisely, it aims :
- to evaluate the heterogeneity of brain perfusion and thus diagnose brain tissue hypoperfusion with contrast-enhanced ultrasound.
- to correlate contrast-enhanced ultrasound with perfusion measurements by usual multimodal monitoring.
Read the detailed description
The main aim is to evaluate the heterogeneity of brain perfusion, thus diagnosing brain tissue hypoperfusion with PerCEUS, then to correlate it with the usual multimodal monitoring.
Earlier after hospitalization in neurointensive care, when the study physician needs to realize a contrast ultrasound imaging and without delaying any emergency procedure, a PerCEUS will be performed in patients with an acute brain injury. After acquisition, data from PerCEUS will be transferred to an external evaluation unit and analysed offline, using commercially available software Qlab (Philips ®). According to the localization of acute brain injuries with magnetic resonance imaging (MRI) and/or computed tomography (CT), several regions-of-interest (ROI, at least three in each area) will be chosen :
- Area 1 : in the core of the lesion (supposed non perfused)
- Area 2 : just next to the lesion (supposed hypoperfused)
- Area 3 : in the saner hemisphere, symmetrically to area 2 each time it's possible (supposed well-perfused).
Every parameters of multimodal monitoring used at the moment of PerCEUS will be relieved :
- intracranial pressure (ICP), cerebral perfusion pressure (CPP), mean arterial pressure (MAP)
- mean flow velocity (MFV) by transcranial doppler (TCD)
- regional cerebral oxygen saturation (rSO2) by Near infrared spectroscopy (NIRS)
- jugular venous oximetry (SjvO2).
The actual PerCEUS measurement takes place at the bedside, is performed by the study physician, and takes about 5 minutes.
The trial duration per patient is 30 minutes, ending after 25 minutes of oversight
- Conditions
- Cerebral Hemorrhage, Subarachnoid Hemorrhage, Ischemic Stroke, Cerebrovascular Circulation, Perfusion
- Being tested
- Measuring contrast-enhanced ultrasound perfusion with phase inversion harmonic imaging
- Keywords
- Brain perfusion, Cerebral blood flow, Diagnostic imaging, Ultrasonography Doppler, Doppler ultrasound, Transcranial Doppler, Contrast enhanced ultrasound, Contrast-enhanced ultrasonography, Contrast ultrasound, Ultrasound perfusion imaging, Ultrasound contrast agent, Intra-cranial pressure, Intracerebral hematoma, Neurocritical care
- Medical subject headings
- Cerebral Hemorrhage, Subarachnoid Hemorrhage, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring contrast-enhanced ultrasound perfusion with phase inversion harmonic imagingDiagnostic test
Contrast-enhanced ultrasound perfusion imaging (PerCEUS) will be performed by a dedicated study team. The transcranial color duplex sonography will be performed with a 1-5 MHz dynamic sector array (S5-1) from a Philips Epiq 7 ultrasound machine (Philips Healthcare, Andover, MA). The field-of-view will be set to an imaging depth of 150 mm in a sector angle of 90°. The imaging plane will be then tilted to the diencephalic, in which the frontal horns of the side ventricles and the third ventricle serve as landmarks and where the anterior and posterior middle cerebral artery (MCA) territory and the basal ganglia (BG) as region of interest could be identified without artefacts from major vessels. High mechanical index bolus imaging will be performed from the sanest side of the head. Data acquisition of 45 seconds will be recorded immediately after the beginning of the contrast ultrasound imaging, using a mechanical index (MI) setting of 1.1 and a frame rate of 33 Hz.
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute brain injuries when a contrast ultrasound imaging is requested by the physician | Contrast-enhanced ultrasound perfusion imaging (PerCEUS) Receives: Diagnostic Test: Measuring contrast-enhanced ultrasound perfusion with phase inversion harmonic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the heterogeneity of brain perfusion by time-to-peak (TPI) measurement
Comparison between time-to-peak (TPI) intensities measured in ROIs in each area by PerCEUS
Measured: 30 minutes after PerCEUS
Evaluation of the heterogeneity of brain perfusion by peak-intensities (PI) measurement
Comparison between peak-intensities (PI) measured in ROIs in each area by PerCEUS
Measured: 30 minutes after PerCEUS
Secondary outcomes (4)
Correlation between PerCEUS parameters and cerebral perfusion as assessed by ICP and MAP
Correlations test between TPI/PI and ICP/CPP/MAP
Measured: 30 minutes after PerCEUS
Correlation between PerCEUS parameters and cerebral perfusion as assessed by TCD
Correlations test between TPI/PI and MFV
Measured: 30 minutes after PerCEUS
Correlation between PerCEUS parameters and cerebral perfusion as assessed by NIRS
orrelations test between TPI/PI and rSO2
Measured: 30 minutes after PerCEUS
Correlation between PerCEUS parameters and cerebral perfusion as assessed by SjvO2
Correlations test between TPI/PI and SjvO2
Measured: 30 minutes after PerCEUS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start21 Jul 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain BARTHELEMY, MD, Principal investigator, AP-HP Lariboisière Hospital, Department of Anaesthesia and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893407
- Sponsor's protocol ID
- APHP230489
- Other IDs
- 2023-A00939-36
- Acronym
- PerCEUS
- Status last verified
- Jun 2025
- First submitted
- 29 May 2023
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eyding J, Krogias C, Wilkening W, Postert T. Detection of cerebral perfusion abnormalities in acute stroke using phase inversion harmonic imaging (PIHI): preliminary results. J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):926-9. doi: 10.1136/jnnp.2003.026195.
PubMed 15146019Eyding J, Fung C, Niesen WD, Krogias C. Twenty Years of Cerebral Ultrasound Perfusion Imaging-Is the Best yet to Come? J Clin Med. 2020 Mar 17;9(3):816. doi: 10.3390/jcm9030816.
PubMed 32192077Vinke EJ, Kortenbout AJ, Eyding J, Slump CH, van der Hoeven JG, de Korte CL, Hoedemaekers CWE. Potential of Contrast-Enhanced Ultrasound as a Bedside Monitoring Technique in Cerebral Perfusion: a Systematic Review. Ultrasound Med Biol. 2017 Dec;43(12):2751-2757. doi: 10.1016/j.ultrasmedbio.2017.08.935. Epub 2017 Sep 28.
PubMed 28964614Fung C, Heiland DH, Reitmeir R, Niesen WD, Raabe A, Eyding J, Schnell O, Rolz R, Z Graggen WJ, Beck J. Ultrasound Perfusion Imaging for the Detection of Cerebral Hypoperfusion After Aneurysmal Subarachnoid Hemorrhage. Neurocrit Care. 2022 Aug;37(1):149-159. doi: 10.1007/s12028-022-01460-z. Epub 2022 Feb 24.
PubMed 35211837Bilotta F, Robba C, Santoro A, Delfini R, Rosa G, Agati L. Contrast-Enhanced Ultrasound Imaging in Detection of Changes in Cerebral Perfusion. Ultrasound Med Biol. 2016 Nov;42(11):2708-2716. doi: 10.1016/j.ultrasmedbio.2016.06.007. Epub 2016 Jul 27.
PubMed 27475927
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Cerebral Perfusion at the Patient's Bedside When Performing Contrast-enhanced Ultrasound in Neurointensive Care Patients
- ClinicalTrials.gov ID
- NCT05893407
- Acronym / sponsor ID
- PerCEUS / APHP230489
- Conditions
- Cerebral Hemorrhage, Subarachnoid Hemorrhage, Ischemic Stroke, Cerebrovascular Circulation, Perfusion
- Keywords
- Brain perfusion, Cerebral blood flow, Diagnostic imaging, Ultrasonography Doppler, Doppler ultrasound, Transcranial Doppler, Contrast enhanced ultrasound, Contrast-enhanced ultrasonography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to assess brain tissue perfusion by contrast-enhanced ultrasound perfusion imaging (PerCEUS) in acute brain injuries. More precisely, it aims :
- to evaluate the heterogeneity of brain perfusion and thus diagnose brain tissue hypoperfusion with contrast-enhanced ultrasound.
- to correlate contrast-enhanced ultrasound with perfusion measurements by usual multimodal monitoring.
Detailed description
The main aim is to evaluate the heterogeneity of brain perfusion, thus diagnosing brain tissue hypoperfusion with PerCEUS, then to correlate it with the usual multimodal monitoring.
Earlier after hospitalization in neurointensive care, when the study physician needs to realize a contrast ultrasound imaging and without delaying any emergency procedure, a PerCEUS will be performed in patients with an acute brain injury. After acquisition, data from PerCEUS will be transferred to an external evaluation unit and analysed offline, using commercially available software Qlab (Philips ®). According to the localization of acute brain injuries with magnetic resonance imaging (MRI) and/or computed tomography (CT), several regions-of-interest (ROI, at least three in each area) will be chosen :
- Area 1 : in the core of the lesion (supposed non perfused)
- Area 2 : just next to the lesion (supposed hypoperfused)
- Area 3 : in the saner hemisphere, symmetrically to area 2 each time it's possible (supposed well-perfused).
Every parameters of multimodal monitoring used at the moment of PerCEUS will be relieved :
- intracranial pressure (ICP), cerebral perfusion pressure (CPP), mean arterial pressure (MAP)
- mean flow velocity (MFV) by transcranial doppler (TCD)
- regional cerebral oxygen saturation (rSO2) by Near infrared spectroscopy (NIRS)
- jugular venous oximetry (SjvO2).
The actual PerCEUS measurement takes place at the bedside, is performed by the study physician, and takes about 5 minutes.
The trial duration per patient is 30 minutes, ending after 25 minutes of oversight
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute brain injuries when a contrast ultrasound imaging is requested by the physician | – | Diagnostic Test: Measuring contrast-enhanced ultrasound perfusion with phase inversion harmonic imagingContrast-enhanced ultrasound perfusion imaging (PerCEUS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in neurosurgical intensive care in Lariboisière Hospital, Paris, with acute brain injuries
Key inclusion criteria (5 listed)
- Age ≥18
- Intensive care unit admission for acute brain injury
- Proven acute brain injury by CT and/or MRI
- Requiring a contrast ultrasound imaging
- Informed consent of patient or relative
Key exclusion criteria (4 listed)
- Pregnancy
- Not sufficient temporal window
- Contraindications to Sonovue ® : acute coronary syndromes, severe ischemic heart disease (requiring revascularization), pulmonary arterial hypertension > 90 mmHg, right-left shunt, ARDS, dobutamine's use, known allergy or adverse reaction to Sonovue®
- Patient on State Medical Assistance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measuring contrast-enhanced ultrasound perfusion with phase inversion harmonic imagingContrast-enhanced ultrasound perfusion imaging (PerCEUS) will be performed by a dedicated study team. The transcranial color duplex sonography will be performed with a 1-5 MHz dynamic sector array (S5-1) from a Philips Epiq 7 ultrasound machine (Philips Healthcare, Andover, MA). The field-of-view will be set to an imaging depth of 150 mm in a sector angle of 90°. The imaging plane will be then tilted to the diencephalic, in which the frontal horns of the side ventricles and the third ventricle serve as landmarks and where the anterior and posterior middle cerebral artery (MCA) territory and the basal ganglia (BG) as region of interest could be identified without artefacts from major vessels. High mechanical index bolus imaging will be performed from the sanest side of the head. Data acquisition of 45 seconds will be recorded immediately after the beginning of the contrast ultrasound imaging, using a mechanical index (MI) setting of 1.1 and a frame rate of 33 Hz. | Diagnostic test | Patients with acute brain injuries when a contrast ultrasound imaging is requested by the physician |
Primary outcome
Evaluation of the heterogeneity of brain perfusion by time-to-peak (TPI) measurement
Time frame: 30 minutes after PerCEUS
Comparison between time-to-peak (TPI) intensities measured in ROIs in each area by PerCEUS
Evaluation of the heterogeneity of brain perfusion by peak-intensities (PI) measurement
Time frame: 30 minutes after PerCEUS
Comparison between peak-intensities (PI) measured in ROIs in each area by PerCEUS
4 secondary outcomes
Correlation between PerCEUS parameters and cerebral perfusion as assessed by ICP and MAP
Time frame: 30 minutes after PerCEUS
Correlation between PerCEUS parameters and cerebral perfusion as assessed by TCD
Time frame: 30 minutes after PerCEUS
Correlation between PerCEUS parameters and cerebral perfusion as assessed by NIRS
Time frame: 30 minutes after PerCEUS
Correlation between PerCEUS parameters and cerebral perfusion as assessed by SjvO2
Time frame: 30 minutes after PerCEUS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Background: PubMed 15146019Eyding J, Krogias C, Wilkening W, Postert T. Detection of cerebral perfusion abnormalities in acute stroke using phase inversion harmonic imaging (PIHI): preliminary results. J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):926-9. doi: 10.1136/jnnp.2003.026195.
- Background: PubMed 32192077Eyding J, Fung C, Niesen WD, Krogias C. Twenty Years of Cerebral Ultrasound Perfusion Imaging-Is the Best yet to Come? J Clin Med. 2020 Mar 17;9(3):816. doi: 10.3390/jcm9030816.
- Background: PubMed 28964614Vinke EJ, Kortenbout AJ, Eyding J, Slump CH, van der Hoeven JG, de Korte CL, Hoedemaekers CWE. Potential of Contrast-Enhanced Ultrasound as a Bedside Monitoring Technique in Cerebral Perfusion: a Systematic Review. Ultrasound Med Biol. 2017 Dec;43(12):2751-2757. doi: 10.1016/j.ultrasmedbio.2017.08.935. Epub 2017 Sep 28.
- Background: PubMed 35211837Fung C, Heiland DH, Reitmeir R, Niesen WD, Raabe A, Eyding J, Schnell O, Rolz R, Z Graggen WJ, Beck J. Ultrasound Perfusion Imaging for the Detection of Cerebral Hypoperfusion After Aneurysmal Subarachnoid Hemorrhage. Neurocrit Care. 2022 Aug;37(1):149-159. doi: 10.1007/s12028-022-01460-z. Epub 2022 Feb 24.
- Background: PubMed 27475927Bilotta F, Robba C, Santoro A, Delfini R, Rosa G, Agati L. Contrast-Enhanced Ultrasound Imaging in Detection of Changes in Cerebral Perfusion. Ultrasound Med Biol. 2016 Nov;42(11):2708-2716. doi: 10.1016/j.ultrasmedbio.2016.06.007. Epub 2016 Jul 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Romain BARTHELEMY, MD principal investigator
AP-HP Lariboisière Hospital, Department of Anaesthesia and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Hemorrhage and Subarachnoid Hemorrhage, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romain BARTHELEMY, MD (+33 (0)1 49 95 85 15, romain.barthelemy@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the heterogeneity of brain perfusion by time-to-peak (TPI) measurement (time frame: 30 minutes after PerCEUS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05893407, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.