Cerebral Hematoma, TraumaticMEANSNCT00918970
Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death
An observational study of Cerebral Hematoma, Traumatic and Intracerebral Hemorrhage, Traumatic, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial summary
Context: A major lack of organ donors is a serious public health problem. It determines a prolonged delay before a transplant can be performed and thus a significant number of deaths of patients waiting for transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Hematoma, Traumatic, Intracerebral Hemorrhage, Traumatic, Traumatic Brain Hemorrhage
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- Aug 2008to Jun 2009
- 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: subjects with severe cerebral lesions admitted in intensive care units
Who may be able to join
- severe cerebral lesions
- admitted in intensive care units
Who cannot join
- neoplastic pathology
- prior myocardiac infarction
- hearth failure
- atrial fibrillation
- insulin-treated diabetes mellitus
- cardiac pacemaker
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Dijon
Dijon, 21000
CH Roanne
Roanne, 42700
CHU de Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death: the MEANS Study
Context: A major lack of organ donors is a serious public health problem. It determines a prolonged delay before a transplant can be performed and thus a significant number of deaths of patients waiting for transplantation. The aim of this project is to reduce the delay of the diagnosis of brain death, and also to improve its diagnosis in the Intensive Care Unit.
The diagnosis of brain death is strictly defined by the law and relies either on two consecutive flat electroencephalograms recorded at an interval of four hours, or on the lack of cerebral circulation during a brain angiography performed after suspecting brain death on the clinical exam. However, in usual practice, it is difficult to have all the needed clinical arguments, and their interpretation can be difficult in the pathological context. This may participate in the delay and the lack of patients potentially donors.
Pre-study: In a pilot study, fifty subjects with severe cerebral lesions, had a continuous ECG recording. The investigators could find that a decrease in autonomic nervous system activity, as measured through the ECG, was correlated to the transition to brain death assessed by cerebral angiography. The loss of cardiac variability was always observed between two cerebral angiographies, one before and the second after brain death. This study allowed the investigators to calculate the threshold values of sympathetic and parasympathetic activities to confirm brain death.
Read the detailed description
Aim: The aim of this second study is to validate prospectively the interest of the analysis in real-time of autonomic nervous system activity to detect brain death.
Benefits expected: Increase the number of organ donors and the number of organs removal available for transplantation.
- Conditions
- Cerebral Hematoma, Traumatic, Intracerebral Hemorrhage, Traumatic, Traumatic Brain Hemorrhage, Traumatic Brain Injury
- Keywords
- autonomous nervous system, brain death, organs transplantation
- Medical subject headings
- Cerebral Hemorrhage, Traumatic, Brain Hemorrhage, Traumatic, Brain Injuries, Traumatic, Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SNA group | This group will have a real-time analysis of autonomic nervous system activity during its intensive care hospitalisation | |
| Clinical group | This group will have a conventional clinical analysis during its intensive care hospitalisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the delay between the falling down of autonomic nervous system activity and the confirmation of the brain death using cerebral angiography
Measured: At confirmation of the brain death
Secondary outcomes (1)
the number of patients and the number of organs removed
Measured: At the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startAug 2008
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Angioscanners in excess of the SNA group because of use of thiopental
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Hematoma, TraumaticStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Investigators
- David CHARIER, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918970
- Sponsor's protocol ID
- 0708045
- Other IDs
- CNIL 908.476
- Acronym
- MEANS
- Status last verified
- Jun 2009
- First submitted
- 8 Jun 2009
- Last updated
- 15 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death: the MEANS Study
- ClinicalTrials.gov ID
- NCT00918970
- Acronym / sponsor ID
- MEANS / 0708045
- Conditions
- Cerebral Hematoma, Traumatic, Intracerebral Hemorrhage, Traumatic, Traumatic Brain Hemorrhage, Traumatic Brain Injury
- Keywords
- autonomous nervous system, brain death, organs transplantation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Angioscanners in excess of the SNA group because of use of thiopental
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Aug 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 11 Jun 2009 (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.
Context: A major lack of organ donors is a serious public health problem. It determines a prolonged delay before a transplant can be performed and thus a significant number of deaths of patients waiting for transplantation. The aim of this project is to reduce the delay of the diagnosis of brain death, and also to improve its diagnosis in the Intensive Care Unit.
The diagnosis of brain death is strictly defined by the law and relies either on two consecutive flat electroencephalograms recorded at an interval of four hours, or on the lack of cerebral circulation during a brain angiography performed after suspecting brain death on the clinical exam. However, in usual practice, it is difficult to have all the needed clinical arguments, and their interpretation can be difficult in the pathological context. This may participate in the delay and the lack of patients potentially donors.
Pre-study: In a pilot study, fifty subjects with severe cerebral lesions, had a continuous ECG recording. The investigators could find that a decrease in autonomic nervous system activity, as measured through the ECG, was correlated to the transition to brain death assessed by cerebral angiography. The loss of cardiac variability was always observed between two cerebral angiographies, one before and the second after brain death. This study allowed the investigators to calculate the threshold values of sympathetic and parasympathetic activities to confirm brain death.
Detailed description
Aim: The aim of this second study is to validate prospectively the interest of the analysis in real-time of autonomic nervous system activity to detect brain death.
Benefits expected: Increase the number of organ donors and the number of organs removal available for transplantation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNA group | – | –This group will have a real-time analysis of autonomic nervous system activity during its intensive care hospitalisation |
| Clinical group | – | –This group will have a conventional clinical analysis during its intensive care hospitalisation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects with severe cerebral lesions admitted in intensive care units
Key inclusion criteria (2 listed)
- severe cerebral lesions
- admitted in intensive care units
Key exclusion criteria (6 listed)
- neoplastic pathology
- prior myocardiac infarction
- hearth failure
- atrial fibrillation
- insulin-treated diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the delay between the falling down of autonomic nervous system activity and the confirmation of the brain death using cerebral angiography
Time frame: At confirmation of the brain death
1 secondary outcome
the number of patients and the number of organs removed
Time frame: At the end of the study
Results and safety
The study was stopped early (reason given: Angioscanners in excess of the SNA group because of use of thiopental). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2009.
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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. This study is not recruiting at the moment.
David CHARIER, MD principal investigator
CHU de Saint-Etienne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Hematoma, Traumatic and Intracerebral Hemorrhage, Traumatic, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites 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 2 inclusion and 6 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 15 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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: Angioscanners in excess of the SNA group because of use of thiopental). 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?
the delay between the falling down of autonomic nervous system activity and the confirmation of the brain death using cerebral angiography (time frame: At confirmation of the brain death). 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 15 Jun 2009.