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Clinical Trials/NCT03157453
NCT03157453
Terminated
Not Applicable

Comparison of Two Initial Evaluation Scales of the Severity of Brain Injury Adults

Poitiers University Hospital1 site in 1 country367 target enrollmentStarted: August 7, 2017Last updated:
ConditionsBrain Injury

Overview

Phase
Not Applicable
Status
Terminated
Enrollment
367
Locations
1
Primary Endpoint
Comparison of ROC curve areas of the two scales to predict an unfavorable neurological prognosis at 6 months (GOS-E < or = 5)

Overview

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).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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).

Outcomes

Primary Outcomes

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

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(6 months)
  • Mortality in intensive care unit(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(6 months)
  • Duration of stay at hospital(6 months)
  • Mortality at hospital(6 months)
  • Mortalit at 6 months(6 months)
  • Duration of stay in intensive care unit(6 months)
  • Duration of mechanical ventilation(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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