CASSANDRA: Comparison of Two Initial Evaluation Scales of the Severity of Brain Injury Adults Patients on the Neurological Outcome at 6 Months

Sponsor

Poitiers University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03157453

Collaborator

(none)

2,200

Enrollment

Location

Anticipated Duration (Months)

30.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Brain Injury

Study Design

Study Type:

Observational

Anticipated Enrollment :

2200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 7, 2017

Anticipated Primary Completion Date :

Aug 6, 2023

Anticipated Study Completion Date :

Aug 6, 2023

Outcome Measures

Primary Outcome Measures

Comparison of ROC curve areas of the two scales to predict an unfavorable neurological prognosis at 6 months (GOS-E < or = 5) [6 months]

Secondary Outcome Measures

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]
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]
Mortality in intensive care unit [6 months]
Duration of stay in intensive care unit [6 months]
Duration of mechanical ventilation [6 months]
Mortality at hospital [6 months]
Mortalit at 6 months [6 months]
Duration of stay at hospital [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).