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

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ClinicalTrials.gov Identifier: NCT03157453
Recruitment Status : Recruiting
First Posted : May 17, 2017
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease
Brain Injury

Study Type : Observational
Estimated 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 : August 1, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 [ Time Frame: 6 months ]
  2. 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 [ Time Frame: 6 months ]
  3. Mortality in intensive care unit [ Time Frame: 6 months ]
  4. Duration of stay in intensive care unit [ Time Frame: 6 months ]
  5. Duration of mechanical ventilation [ Time Frame: 6 months ]
  6. Mortality at hospital [ Time Frame: 6 months ]
  7. Mortalit at 6 months [ Time Frame: 6 months ]
  8. Duration of stay at hospital [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03157453


Contacts
Contact: Guenezan Mr Jeremy +33549443694 jeremy.guenezan@chu-poitiers.fr
Contact: Seguin Mrs Sabrina +33549443229 sabrina.seguin@chu-poitiers.fr

Locations
France
CHU of Poitiers Recruiting
Poitiers, France, 86021
Contact: Guenezan Mr Jeremy    +33549443694    jeremy.guenezan@chu-poitiers.fr   
Contact: Seguin Mrs Sabrina    +33549443229    sabrina.seguin@chu-poitiers.fr   
Sponsors and Collaborators
Poitiers University Hospital

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03157453     History of Changes
Other Study ID Numbers: CASSANDRA
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Poitiers University Hospital:
Evaluation scale
Brain injury
Severity of Brain Injury
Initial Evaluation

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System