Clinical trial NCT03157453: Comparison of Two Initial Evaluation Scales of the Severity of Brain Injury Adults Patients on the Neurological Outcome at 6 Months
Official title: Comparison of Two Initial Evaluation Scales of the Severity of Brain Injury Adults
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Brain Injury
Keywords: Evaluation scale
Brain injury
Severity of Brain Injury
Initial Evaluation
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Comparison of ROC curve areas of the two scales to predict an unfavorable neurological prognosis at 6 months (GOS-E < or = 5)
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: Mortality in intensive care unit
timeFrame: 6 months
measure: Duration of stay in intensive care unit
timeFrame: 6 months
measure: Duration of mechanical ventilation
timeFrame: 6 months
measure: Mortality at hospital
timeFrame: 6 months
measure: Mortalit at 6 months
timeFrame: 6 months
measure: Duration of stay at hospital
timeFrame: 6 months
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU of Poitiers
Study officials:
References: