Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Severe and Moderate Traumatic Brain Injury (PREDICT-TBI)
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|ClinicalTrials.gov Identifier: NCT03874546|
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : April 17, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Other: Questionnaire||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Traumatic Brain Injury.|
|Actual Study Start Date :||April 4, 2019|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: Prognostic evaluation
Questionnaire at Day1, Day7 and 6 months.
Other Name: French language questionnaire for clinicians that analyses the clinician's perception of the patient's prognosis
- 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. [ Time Frame: At 6 month ]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.
- Differences in prognosis between clinicians based on their experience and specialty. [ Time Frame: At 6 months ]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.
- To compare the quality of the prognosis of the clinicians between the 1st day (D1) and the 7th day (D7) post-traumatic. [ Time Frame: At 6 months ]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.
- Evaluate how the clinician's confidence in his prognosis is related to the quality of the prognosis. [ Time Frame: At 6 months ]Evaluation of the effect of the clinician's confidence in his prognosis on the clinician's prognostic ROC curve.
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): NCT03874546
|Contact: Rémy BERNARD, MD||01 84 82 75 78 ext +email@example.com|
|Contact: Vincent DEGOS, MD-PhD||01 84 82 71 79 ext +firstname.lastname@example.org|
|Réanimation neurochirurgicale, Hôpital Pitié-Salpêtrière||Recruiting|
|Paris, France, 75013|
|Contact: REMY BERNARD, MD|
|Contact: Vincent DEGOS, MD-PhD|
|Principal Investigator:||Rémy BERNARD, MD||Assistance Publique Hoptiaux de Paris|