Traumatic Brain InjuryPREDICT-TBINCT03874546
Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Severe and Moderate Traumatic Brain Injury
A study testing Questionnaire in people with Traumatic Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2019to 22 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Réanimation neurochirurgicale, Hôpital Pitié-Salpêtrière
Paris, 75013
About this study
Official title: Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Traumatic Brain Injury.
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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Questionnaire
- Keywords
- Severe and moderate traumatic brain injury, Prognosis, IMPACT score
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Also called French language questionnaire for clinicians that analyses the clinician's perception of the patient's prognosis
- 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).
| Study group | Role | What they receive |
|---|---|---|
| Prognostic evaluation | Experimental | Questionnaire at Day1, Day7 and 6 months. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 month
Secondary outcomes (3)
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.
Measured: At 6 months
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.
Measured: At 6 months
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.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start4 Apr 2019
- Primary completion22 Feb 2021
- Study completion22 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rémy BERNARD, MD, Principal investigator, Assistance Publique Hoptiaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874546
- Sponsor's protocol ID
- APHP180477
- Other IDs
- 2018-A03135-50
- Acronym
- PREDICT-TBI
- Status last verified
- Feb 2021
- First submitted
- 12 Mar 2019
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Traumatic Brain Injury.
- ClinicalTrials.gov ID
- NCT03874546
- Acronym / sponsor ID
- PREDICT-TBI / APHP180477
- Conditions
- Traumatic Brain Injury
- Keywords
- Severe and moderate traumatic brain injury, Prognosis, IMPACT score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 22 Sep 2021 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prognostic evaluation | Experimental | Other: QuestionnaireQuestionnaire at Day1, Day7 and 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: French language questionnaire for clinicians that analyses the clinician's perception of the patient's prognosis* 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 | Prognostic evaluation |
Primary outcome
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.
3 secondary outcomes
Differences in prognosis between clinicians based on their experience and specialty.
Time frame: At 6 months
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
Evaluate how the clinician's confidence in his prognosis is related to the quality of the prognosis.
Time frame: At 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rémy BERNARD, MD principal investigator
Assistance Publique Hoptiaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Traumatic Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: At 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.