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

NCT03157453 | Terminated

• 1 other identifier: CASSANDRA
• Study Type: observational
• Target: 367
• Locations: 1 country
• Sites: 1

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).

Conditions

Brain Injury

Keywords

Evaluation scale; Brain injury; Severity of Brain Injury; Initial Evaluation

Outcome Measures

Primary Outcomes (1)

• 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 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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU of Poitiers

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: May 17, 2017
• Study Start: August 7, 2017
• Primary Completion: June 2, 2022
• Study Completion: December 2, 2022
• Last Updated: January 12, 2024

Record last verified: 2024-01

Locations

FR (1)