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

Brain Injury Clinical Trial

— CASSANDRA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03157453
• Other study ID #: CASSANDRA
• Status: Terminated
• Start date: August 7, 2017
• Est. completion date: December 2, 2022

Study information

• Verified date: January 2024
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 367
• Est. completion date: December 2, 2022
• Est. primary completion date: June 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
France	CHU of Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Mortality in intensive care unit		6 months
Secondary	Duration of stay in intensive care unit		6 months
Secondary	Duration of mechanical ventilation		6 months
Secondary	Mortality at hospital		6 months
Secondary	Mortalit at 6 months		6 months
Secondary	Duration of stay at hospital		6 months