Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Severe and Moderate Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— PREDICT-TBI  

Official title:

Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Traumatic Brain Injury.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03874546
• Other study ID #: APHP180477
• Secondary ID: 2018-A03135-50
• Status: Completed
• Phase: N/A
• Start date: April 4, 2019
• Est. completion date: September 22, 2021

Study information

• Verified date: February 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: September 22, 2021
• Est. primary completion date: February 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Questionnaire
Two clinicians will complete a questionnaire that analyses their perception of the patient's prognosis at Day1 and Day7. At 6 months, another clinician will establish the patient prognosis using Glasgow Outcome Scale and Glasgow outcome scale extended. This clinician must not know the patient's IMPACT score and prognosis established at Day 1 and Day 7. His evaluation will be compare to the patient's prognosis established previously (Day1 and Day7).

Locations

Country	Name	City	State
France	Réanimation neurochirurgicale, Hôpital Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Comparison of the area under the ROC curve of the IMPACT model score for the prediction of the 6-month Glasgow Outcome Scale (GOS) = 3 to the area under the ROC curve of the first day clinician's prediction.	At 6 month
Secondary	Differences in prognosis between clinicians based on their experience and specialty.	Evaluation of the effect of the clinician's experience (number of years of neuro-ICU exercise) and specialty on the clinician's prognosis ROC curve.	At 6 months
Secondary	To compare the quality of the prognosis of the clinicians between the 1st day (D1) and the 7th day (D7) post-traumatic.	Comparison between the clinician's ROC curves at D1 (between the 6th and the 24th hour) and at D7 of the trauma for the prognosis of the patient.	At 6 months
Secondary	Evaluate how the clinician's confidence in his prognosis is related to the quality of the prognosis.	Evaluation of the effect of the clinician's confidence in his prognosis on the clinician's prognostic ROC curve.	At 6 months