Brain InjuryCASSANDRANCT03157453
Comparison of Two Initial Evaluation Scales of the Severity of Brain Injury Adults Patients on the Neurological Outcome at 6 Months
An observational study of Brain Injury, run by Poitiers University Hospital at 1 site in France.
Trial summary
Prospective cohort study. Any patient with potential cerebral injured (medical or traumatic) will be included in the study, regardless of its severity, history, the presence of anticoagulant or antiagrégant. The collection should be done as soon as possible, in the reception of vital emergencies or in the urgencies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury
- How many people
- 367 participants
- Where
- 1 siteFrance
- Study dates
- 7 Aug 2017to 2 Dec 2022
- 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: Any patient with potential cerebral injured (medical or traumatic) will be included in the study, regardless of its severity, history, the presence of anticoagulant or antiagrégant.
Who may be able to join
- All patients aged 18 years or more
- Potentially Victim of a cerebral injury whatever the level of severity
- Having a calculation of GCS and KBS on arrival at the hospital (emergency room)
- Affiliated to a social security scheme or benefiting through a third person.
Who cannot join
- Pregnant women
- Patients who refusing to participate in research
- Patients undergoing enhanced protection (persons deprived of liberty by a judicial or administrative decision, adults under legal protection).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Initial Evaluation Scales of the Severity of Brain Injury Adults
Prospective cohort study. Any patient with potential cerebral injured (medical or traumatic) will be included in the study, regardless of its severity, history, the presence of anticoagulant or antiagrégant.
The collection should be done as soon as possible, in the reception of vital emergencies or in the urgencies. The collection consists of the realization of a Glasgow score and a scale of Kremlin-Bicêtre for all patients by completing a standardized collection sheet. The collection of GCS and Kremlin-Bicêtre must be did at the same time. The collection sheet is filled by medical personnel trained.
The future of the patient is informed at 6 months using the Glasgow Outcome Scale- Extended, which will be made during a following consultation or by phone. Additional data will be collected on the folder (ventilation time, days of hospitalization, mortality).
- Conditions
- Brain Injury
- Keywords
- Evaluation scale, Brain injury, Severity of Brain Injury, Initial Evaluation
- Medical subject headings
- Brain Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of ROC curve areas of the two scales to predict an unfavorable neurological prognosis at 6 months (GOS-E < or = 5)
Measured: 6 months
Secondary outcomes (8)
Comparison of ROC curve areas of the two scales to predict an unfavorable neurological prognosis at 6 months (GOS-E < or = 5) for medical injury
Measured: 6 months
Comparison of ROC curve areas of the two scales to predict an unfavorable neurological prognosis at 6 months (GOS-E < or = 5) for traumatized cranial
Measured: 6 months
Mortality in intensive care unit
Measured: 6 months
Duration of stay in intensive care unit
Measured: 6 months
Duration of mechanical ventilation
Measured: 6 months
Mortality at hospital
Measured: 6 months
Mortalit at 6 months
Measured: 6 months
Duration of stay at hospital
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start7 Aug 2017
- Primary completion2 Jun 2022
- Study completion2 Dec 2022
Why it stopped: Recruitment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157453
- Sponsor's protocol ID
- CASSANDRA
- Acronym
- CASSANDRA
- Status last verified
- Jan 2024
- First submitted
- 17 Mar 2017
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Initial Evaluation Scales of the Severity of Brain Injury Adults
- ClinicalTrials.gov ID
- NCT03157453
- Acronym / sponsor ID
- CASSANDRA / CASSANDRA
- Conditions
- Brain Injury
- Keywords
- Evaluation scale, Brain injury, Severity of Brain Injury, Initial Evaluation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment difficulty
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 17 May 2017 (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.
Prospective cohort study. Any patient with potential cerebral injured (medical or traumatic) will be included in the study, regardless of its severity, history, the presence of anticoagulant or antiagrégant.
The collection should be done as soon as possible, in the reception of vital emergencies or in the urgencies. The collection consists of the realization of a Glasgow score and a scale of Kremlin-Bicêtre for all patients by completing a standardized collection sheet. The collection of GCS and Kremlin-Bicêtre must be did at the same time. The collection sheet is filled by medical personnel trained.
The future of the patient is informed at 6 months using the Glasgow Outcome Scale- Extended, which will be made during a following consultation or by phone. Additional data will be collected on the folder (ventilation time, days of hospitalization, mortality).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with potential cerebral injured (medical or traumatic) will be included in the study, regardless of its severity, history, the presence of anticoagulant or antiagrégant.
Key inclusion criteria (4 listed)
- All patients aged 18 years or more
- Potentially Victim of a cerebral injury whatever the level of severity
- Having a calculation of GCS and KBS on arrival at the hospital (emergency room)
- Affiliated to a social security scheme or benefiting through a third person.
Key exclusion criteria (3 listed)
- Pregnant women
- Patients who refusing to participate in research
- Patients undergoing enhanced protection (persons deprived of liberty by a judicial or administrative decision, adults under legal protection).
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
Comparison of ROC curve areas of the two scales to predict an unfavorable neurological prognosis at 6 months (GOS-E < or = 5)
Time frame: 6 months
8 secondary outcomes
Comparison of ROC curve areas of the two scales to predict an unfavorable neurological prognosis at 6 months (GOS-E < or = 5) for medical injury
Time frame: 6 months
Comparison of ROC curve areas of the two scales to predict an unfavorable neurological prognosis at 6 months (GOS-E < or = 5) for traumatized cranial
Time frame: 6 months
Mortality in intensive care unit
Time frame: 6 months
Duration of stay in intensive care unit
Time frame: 6 months
Duration of mechanical ventilation
Time frame: 6 months
Mortality at hospital
Time frame: 6 months
Mortalit at 6 months
Time frame: 6 months
Duration of stay at hospital
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Recruitment difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Injury, run by Poitiers University Hospital 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 3 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 12 Jan 2024. 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: Recruitment difficulty). 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?
Comparison of ROC curve areas of the two scales to predict an unfavorable neurological prognosis at 6 months (GOS-E < or = 5) (time frame: 6 months). 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 12 Jan 2024.