Acute Brain InjuryFBW-ICUNCT02832895
Frontal Bone Window in ICUF (FBW-ICU)
A study testing Transcranial doppler examination in people with Acute Brain Injury, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Transcranial doppler (TCD) is an established tool for monitoring flows in intracranial cerebral arteries. Its use is recommanded in the last guidelines on traumatic brain injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Brain Injury
- What is being tested?
- Transcranial doppler examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to 30 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Membership in a health insurance scheme
- Patients with an acute cerebral pathology
- Hospitalized patients in a supportive care unit of Montpellier University Hospital
- Be able to benefit from transcranial doppler within 3 days of admission
Who cannot join
- Clinical suspicion of encephalic death
- Known allergy to ultrasound gel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Frontal Bone Window for Transcranial Doppler Among Acute Brain Injured Patients in Intensive Care Units: a Prospective Study.
Transcranial doppler (TCD) is an established tool for monitoring flows in intracranial cerebral arteries. Its use is recommanded in the last guidelines on traumatic brain injury. The temporal bone window (TBW) is limited in evaluating flow in the anterior cerebral arteries (ACA) because of an unfavorable insonation angle. Thereby TCD could be unfit to detect a segmental lesion on the anterior cerebral arteries (ACA).
The frontal bone window (FBW) is a promising approach in evaluating flows in the ACA. However, the utility of the FBW for patients with acute brain injury (ABI) in ICU has not been yet determined.
The goal of the present study is to determine the rate of detection of the ACA by using the FBW in patients with ABI in ICU.
- Conditions
- Acute Brain Injury
- Being tested
- Transcranial doppler examination
- Keywords
- Adults, Frontal bone window, Transcranial doppler
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial doppler examinationOther
Assessment of frontal bone window for transcranial doppler
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Doppler examination | Experimental | Transcranial Doppler examination Receives: Other: Transcranial doppler examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
measures of ACA flow velocities threw the frontal bone window
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJul 2015
- Primary completion30 Sep 2016
- Study completion30 Dec 2016
Why it stopped: Conducting an interim analysis that allowed with the number of patients included of 150 to meet the objectives of this research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille CM Maury, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832895
- Sponsor's protocol ID
- 9489
- Other IDs
- 2014-A01436-41
- Acronym
- FBW-ICU
- Status last verified
- Jan 2018
- First submitted
- 12 Jul 2016
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Frontal Bone Window for Transcranial Doppler Among Acute Brain Injured Patients in Intensive Care Units: a Prospective Study.
- ClinicalTrials.gov ID
- NCT02832895
- Acronym / sponsor ID
- FBW-ICU / 9489
- Conditions
- Acute Brain Injury
- Keywords
- Adults, Frontal bone window, Transcranial doppler
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Conducting an interim analysis that allowed with the number of patients included of 150 to meet the objectives of this research
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 14 Jul 2016 (estimated)
- 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.
Transcranial doppler (TCD) is an established tool for monitoring flows in intracranial cerebral arteries. Its use is recommanded in the last guidelines on traumatic brain injury. The temporal bone window (TBW) is limited in evaluating flow in the anterior cerebral arteries (ACA) because of an unfavorable insonation angle. Thereby TCD could be unfit to detect a segmental lesion on the anterior cerebral arteries (ACA).
The frontal bone window (FBW) is a promising approach in evaluating flows in the ACA. However, the utility of the FBW for patients with acute brain injury (ABI) in ICU has not been yet determined.
The goal of the present study is to determine the rate of detection of the ACA by using the FBW in patients with ABI in ICU.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial Doppler examination | Experimental | Other: Transcranial doppler examinationTranscranial Doppler examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Membership in a health insurance scheme
- Patients with an acute cerebral pathology
- Hospitalized patients in a supportive care unit of Montpellier University Hospital
- Be able to benefit from transcranial doppler within 3 days of admission
Key exclusion criteria (2 listed)
- Clinical suspicion of encephalic death
- Known allergy to ultrasound gel
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 |
|---|---|---|
| Transcranial doppler examinationAssessment of frontal bone window for transcranial doppler | Other | Transcranial Doppler examination |
Primary outcome
measures of ACA flow velocities threw the frontal bone window
Time frame: up to 72 hours
Results and safety
The study was stopped early (reason given: Conducting an interim analysis that allowed with the number of patients included of 150 to meet the objectives of this research). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
Related trials for Acute Brain Injury
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Not yet recruiting
Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
Concussion (Diagnosis), Gait Abnormality
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Active, not recruitingObservational study
Psychoactive Drug Use and Acute Care Use After Trauma and Out-of-Hospital Cardiac Arrest
Wounds and Injuries, Out-of-Hospital Cardiac Arrest
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. This study is not recruiting at the moment.
Camille CM Maury, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial doppler examination in people with Acute Brain Injury, run by University Hospital, Montpellier 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 18 Jan 2018. 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?
The study was stopped early (reason given: Conducting an interim analysis that allowed with the number of patients included of 150 to meet the objectives of this research). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measures of ACA flow velocities threw the frontal bone window (time frame: up to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2018.