Clinical trial NCT03874546: Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Severe and Moderate Traumatic Brain Injury
Official title: Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Traumatic Brain Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Severe and moderate traumatic brain injury
Prognosis
IMPACT score
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Main objective : To compare the quality of the prognostic assessment, (adverse evolution at 6 months) of severe and moderate traumatic brain injury, performed by the clinician compared to the prognosis described by the IMPACT score.

The Pitié-Salpêtrière hospital is conducting a study evaluating the clinician's prognostic assessment of severe and moderate traumatic brain injury compared to the prognosis described by the IMPACT score. The investigators compare the quality of the clinician's prognostic assessment (adverse evolution at 6 months) of severe and moderate traumatic brain injury to the prognosis described by the IMPACT score.

Detailed description: Design: Prospective, monocentric, pilot study. The study will be proposed to all patients admitted to the neurosurgical intensive care unit (ICU) at Pitié-Salpêtrière hospital, following a traumatic brain injury (TBI), over a period of 1 year. Around 100 patients will be included.

Day 1 : In the first 24 hours after traumatic brain injury, two clinicians will respond to the research questionnaire assessing their patient's prognosis, including confidence in their prediction and experience in neurological intensive care unit. The known prognostic variables as the IMPACT score in the first 24 hours will be collected.

Day 7 : The same clinicians will respond to the research questionnaire assessing their patient's prognosis, including confidence in their prediction and experience in neurological intensive care unit.

At 6 months : After 6 months, all patients or relatives will undergo a telephone interview (or if applicable during a follow-up visit in standard care) to assess the Glasgow Outcome Scale (GOS). This interview will be blinded to the clinician's prediction and the IMPACT score. For patients identified as GOS 3 or 4, a second GOS telephone interview will be carry out in the following days (\<7 days), by a committee of adjudication composed of 2 examiners.

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years or older,
* Hospitalized in the neurosurgical ICU department of the Pitié-Salpêtrière hospital following a head trauma,
* Presenting a Glasgow Coma Scale (GCS) ≤ 12 in the first 24 hours following the head trauma,
* Relatives informed of the research and not having objected to the patient's participation in the study.

Exclusion Criteria:

* Opposition of the patient,
* Patient under the protection of justice,
* Pregnant woman,
* Modified scale of Rankin\> 1 before the traumatic brain injury.
* Patient unable to speak French.

Primary outcomes:
measure: Compare the quality of the prognostic assessment of severe and moderate traumatic brain injury, performed by the clinician compared to the prognosis described by the IMPACT score.
timeFrame: At 6 month
Secondary outcomes:
measure: Differences in prognosis between clinicians based on their experience and specialty.
timeFrame: At 6 months
measure: To compare the quality of the prognosis of the clinicians between the 1st day (D1) and the 7th day (D7) post-traumatic.
timeFrame: At 6 months
measure: Evaluate how the clinician's confidence in his prognosis is related to the quality of the prognosis.
timeFrame: At 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Réanimation neurochirurgicale, Hôpital Pitié-Salpêtrière
Study officials:
affiliation: Assistance Publique Hoptiaux de Paris
name: Rémy BERNARD, MD
role: PRINCIPAL_INVESTIGATOR
References: