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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Other: Questionnaire Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prognostic evaluation
Questionnaire at Day1, Day7 and 6 months.
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).
Other Name: French language questionnaire for clinicians that analyses the clinician's perception of the patient's prognosis




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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

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): NCT03874546


Contacts
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Contact: Rémy BERNARD, MD 01 84 82 75 78 ext +33 remy.bernard@aphp.fr
Contact: Vincent DEGOS, MD-PhD 01 84 82 71 79 ext +33 vincent.degos@aphp.fr

Locations
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France
Réanimation neurochirurgicale, Hôpital Pitié-Salpêtrière Recruiting
Paris, France, 75013
Contact: REMY BERNARD, MD         
Contact: Vincent DEGOS, MD-PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Rémy BERNARD, MD Assistance Publique Hoptiaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03874546     History of Changes
Other Study ID Numbers: APHP180477
2018-A03135-50 ( Other Identifier: ANSM )
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Severe and moderate traumatic brain injury
Prognosis
IMPACT score

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