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

Terminated

• Conditions: Brain Injury

• Registration Number: NCT03157453
• Lead Sponsor: Poitiers University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-17
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-17
• Study Start: 2017-08-07
• Primary Completion: 2022-06-02
• Study Completion: 2022-12-02
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 367

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Mortalit at 6 months	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 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
Duration of stay in intensive care unit	6 months
Duration of mechanical ventilation	6 months

Trial Locations

Locations (1)

CHU of Poitiers; 🇫🇷 Poitiers, France