Brain DeadNCT01070563
Transcranial Doppler Ultrasonography and Brain Death
An observational study of Brain Dead, run by Institut d'Anesthesiologie des Alpes Maritimes at 1 site in France.
Trial summary
In France the diagnosis of brain death relies on electroencephalography (EEG) or cerebral angiography. Concerning the latter a time of 6 hours is mandatory between the clinical diagnosis and the realization of the cerebral computed tomography (CT) angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Dead
- What is being tested?
- Transcranial doppler
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Jun 2011
- Phase
- Observational
- 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
Study population: ICU patients showing brain injury due to stroke or trauma and developping subsequently brain death
Who may be able to join
- brain death patients
Who cannot join
- craniectomy
- post anoxia encephalopathy
- no TCD performed before the clinical diagnosis of brain death
- transtemporal approach impossible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Transcranial Doppler Ultrasonography to Guide the Time of Cerebral Angiography for the Brain Death Diagnosis
In France the diagnosis of brain death relies on electroencephalography (EEG) or cerebral angiography. Concerning the latter a time of 6 hours is mandatory between the clinical diagnosis and the realization of the cerebral computed tomography (CT) angiography. Transcranial doppler (TCD) is not recommended in the french guidelines for the diagnosis of brain death. In other countries, some flow patterns allow to confirm the diagnosis of brain death. The hypothesis of our study is that TCD could shorten the time between the clinical diagnosis of brain death and the realization of the CT angiography.
- Conditions
- Brain Dead
- Being tested
- Transcranial doppler
- Keywords
- Brain death, CT angiography, Ultrasonography, doppler, transcranial
- Medical subject headings
- Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial dopplerOther
A TCD is performed on all cerebral arteries (mean cerebral arteries, anterior cerebral arteries, basilar trunk, vertebral arteries and carotid arteries) until a flow pattern compatible with brain death is found
| Study group | Role | What they receive |
|---|---|---|
| Usual | CT angiography is performed 6 hours after the clinical diagnosis of brain death. | |
| TCD | When the diagnosis of brain death is made, TCD is performed and then every 2 hours until the flow patterns compatible with brain death are found. Then a CT angiography is performed. Receives: Other: Transcranial doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time between clinical diagnosis of brain death and realization of CT angiography
Measured: the outcome is assessed when the CT angiography is performed
Secondary outcomes (1)
Number of CT angiography required for the diagnosis of brain death
Measured: the outcome is measured until the diagnosis of brain death is confirmed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startFeb 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain DeadStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Anesthesiologie des Alpes Maritimes
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Christophe Orban, MD, Principal investigator, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070563
- Sponsor's protocol ID
- IAAM 2010-1
- Status last verified
- Jun 2011
- First submitted
- 12 Feb 2010
- Last updated
- 4 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Orban JC, El-Mahjoub A, Rami L, Jambou P, Ichai C. Transcranial Doppler shortens the time between clinical brain death and angiographic confirmation: a randomized trial. Transplantation. 2012 Sep 27;94(6):585-8. doi: 10.1097/TP.0b013e3182612947.
PubMed 22918218
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Transcranial Doppler Ultrasonography to Guide the Time of Cerebral Angiography for the Brain Death Diagnosis
- ClinicalTrials.gov ID
- NCT01070563
- Acronym / sponsor ID
- IAAM 2010-1
- Conditions
- Brain Dead
- Keywords
- Brain death, CT angiography, Ultrasonography, doppler, transcranial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Institut d'Anesthesiologie des Alpes MaritimesUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 Feb 2010 (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.
In France the diagnosis of brain death relies on electroencephalography (EEG) or cerebral angiography. Concerning the latter a time of 6 hours is mandatory between the clinical diagnosis and the realization of the cerebral computed tomography (CT) angiography. Transcranial doppler (TCD) is not recommended in the french guidelines for the diagnosis of brain death. In other countries, some flow patterns allow to confirm the diagnosis of brain death. The hypothesis of our study is that TCD could shorten the time between the clinical diagnosis of brain death and the realization of the CT angiography.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual | – | –CT angiography is performed 6 hours after the clinical diagnosis of brain death. |
| TCD | – | Other: Transcranial dopplerWhen the diagnosis of brain death is made, TCD is performed and then every 2 hours until the flow patterns compatible with brain death are found. Then a CT angiography is performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients showing brain injury due to stroke or trauma and developping subsequently brain death
Key inclusion criteria (1 listed)
- brain death patients
Key exclusion criteria (4 listed)
- craniectomy
- post anoxia encephalopathy
- no TCD performed before the clinical diagnosis of brain death
- transtemporal approach impossible
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 dopplerA TCD is performed on all cerebral arteries (mean cerebral arteries, anterior cerebral arteries, basilar trunk, vertebral arteries and carotid arteries) until a flow pattern compatible with brain death is found | Other | TCD |
Primary outcome
Time between clinical diagnosis of brain death and realization of CT angiography
Time frame: the outcome is assessed when the CT angiography is performed
1 secondary outcome
Number of CT angiography required for the diagnosis of brain death
Time frame: the outcome is measured until the diagnosis of brain death is confirmed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2011.
- Derived from this study: PubMed 22918218Orban JC, El-Mahjoub A, Rami L, Jambou P, Ichai C. Transcranial Doppler shortens the time between clinical brain death and angiographic confirmation: a randomized trial. Transplantation. 2012 Sep 27;94(6):585-8. doi: 10.1097/TP.0b013e3182612947.
Related trials for Brain Dead
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Not yet recruitingObservational study
Brain-based Prediction of the Dying Duration in Humans After Withdrawal of Life Sustaining Therapies to Inform Donation After Circulatory Death
Organ Donation After Circulatory Death
RecruitingPhase 2
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
Recurrent Glioblastoma
Not yet recruitingPhase 3
Cilostazol for Prevention of Recurrent Stroke Trial
Stroke Recurrence, Myocardial Infarction
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.
Jean-Christophe Orban, MD principal investigator
Nice University Hospital
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 Brain Dead, run by Institut d'Anesthesiologie des Alpes Maritimes 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 1 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: finished, as of the sponsor's last update on 4 Jul 2011. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time between clinical diagnosis of brain death and realization of CT angiography (time frame: the outcome is assessed when the CT angiography is performed). 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 NCT01070563, which also lists 1 linked publication.
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 4 Jul 2011.